Standard Jet DBnb` Ugr@?~1y0̝cǟFN7]D^(`T{6}߱wCϯ34ay[|*|OJl>`&_Љ$g'DeFx -{N......r$n\Չ X1s`ԉuxhsxhsxhsOZrKKD KeepLoKKD OrderByOn RowHeight ColumnWidth ColumnOrder ColumnHiddenRequiredAllowZeroLengthDisplayControlFilterOrderByValidationRuleValidationText DescriptionFormat InputMaskCaption DefaultValue!  O ACCESS      mQDATERECD      mP PRODUCT      mQSHRTNAME      mP MFGNAME      mP RPTTYPE      mN MODNO      mN CATNO      mP PROCODE V     mO EDTYPE      mJ DESCRIPTION n(    J FDACOMMENTS     R SPECIALTY      mO ACCTYP U   VCS           2c   ct    j    O        IdParentIdNameType DateCreate DateUpdateOwnerFlagsDatabaseConnect ForeignName RmtInfoShort RmtInfoLongLvLvPropLvModuleLvExtrasetni 2h Id ParentIdName         QUESTION IS A FLUSH DEVICE. THIS FLUSH BECOMES INVOLVED IN THIS EVENT. THE CUSTOMER RETURNED ONE USED SAMPLE TO CO FOR EVALUATION. THIS EVALUATION REVEALED THAT TWO OF THE THREE FLUSH UNITS ON THE DEVICE WERE WITHIN SPECS FOR FLOW RATE. THE THIRD FLUSH UNITT ON THE RETURNED DEVICE EXHIBITED A MUCH HIGHER FLOW RATE THAN IS ACCEPTABLE, VERIFYING THIS COMPLAINT. THE CAUSE OF THIS UNACCEPTABLE FLOW RATE IS UNKNOWN. IT IS POSSIBLE THAT IT RESULTED FROM THE INSTALLATION OF A NEW PIECE OF AUTOMATION EQUIPMENT USED IN THE ASSEMBLY OF VCKS     2  ObjectIdSIDACM FInheritablebc ObjectId..%E 4Z@Yr0fՉs 8Is`ԉux(_x(_x(_EEUU4ZP rfՉt Is`ԉux_x_x_EEEE5ZP,rثfՉu Is`ԉux@_x@_x@_U%EE5Z Tr,fՉv 4Js`ԉuxH_xH_xH_EEEE )5Z@UrfՉw Js`ԉuxP_xP_xP_UUUEE5Z rԬfՉx Js`ԉuxX_xX_xX_EEEE`5Z r(fՉy 0w w wۇ O8V#jKފO\`&_Љ$g'DeFREPORT RECEIVED OF SUDDEN DEATH ON 12/30/95. AT LAST PACEMAKER CHECK ON 12/12/95 PACER FUNCTION WAS NORMAL. PACER IS REPORTED AS UNABLE TO TELEMETER AND HAVING NO OUTPUT. THE PACER WILL BE RETURNED FOR ANALYSIS. LEAD MODEL NO 030-220 SERIAL NO 13391 WAS IN USE WITH THIS PACEMAKER. IMPLANT DURATION: 33 MOS. PRODUCT SAFETY ALERT INITIATED IN THE US N-027/029-5. INITIAL REPORT INDICATED THAT THE PATIENT COMPLAINED OF "LITTLE CUTS IN HIS EYESFROM THE LENSES AND THAT HIS EYES WERE CHECKED IN THE HOSPITAL". A FOLLOW UP WITH THE PRACTITIONER REVEALED THAT THE PATIENT NEVER SOUGHT MEDICAL CARE AT THE HOSPITAL. TH E PRACTITIONER REPORTS THAT HE DID NOT SEE ANYTHING UNUSUAL WITH THE PATIENT'S EYE OR THE LENS. THE PATIENT EXPERIENCED DISCOMFORT UPON INSERTION & TRIED A SECOND LENS. THE DISCOMFORT PERSISTED. THE PRACTITIONER ADVISED NO LENS WEAR FOR 2 WEEKS A ND THEN THE PATIENT RESUMED LENS WEAR WITH NO PROBLEMS.INSPECTION OF THE TWO LENSES RETURNED REVEALED THAT ONE LENS HAD AN IRREGULAR SURFACE AND THE SECOND WAS WITHIN SPECIFICATION. IT CANNOT BE DETERMINED IF THESURFACE IRREGULARITY WOULD HAVE CAUSE D THE PATIENT'S DISCOMFORT. PATIENT'S MOTHER REPORTS THAT HER SON WAS WEARING A 50% WATER TORIC LENS SUCCESSFULLY FOR 5 YEARS AND THEN WAS REFIT INTO A 70% WATER TORIC LENS. HE HAS MANY ALLERGIES AND DRY EYES. HE EXPERIENCED SYMPTOMS OF BURNING AND DRY EYES. WHEN HE RETURNED TO THE DISPENSER HE WAS GIVEN DROPS FOR THE SYMPTOMS. THE LENSES WERE DISCARDED. HE RETURNED TO SCHOOL AND THE CONDITION DID NOT IMPROVE SO HE SAW AN OPHTHAMOLOGIST WHO DIAGNOSED CONJUNCTIVITIS. THE CONDITION CLEARED WITH TREATMENT. HE THEN TRIED A 2ND AND 3RD PAIR AND EXPERIENCED THE SAME SYMPTOMS. HE THEN WENT TO ANOTHER PRACTITIONER WHO REFIT HIM BACK INTO THE TORIC LENS HE WAS PREVIOUSLY WEARING AND HE HAS HAD NO FURTHER PROBLEMS. ONE PAIR OF LENSES ARE TO BE RETURNED FOR EVALUATION. LVALGSr           ObjectId AttriPATIDURING SURGERY WITH FRAME PT ALLEGEDLY EXPERIENCED DECREASED VISION IN THE RIGHT EYE. PT IS 57-YR-OLD. DEVICE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. THE PT REPORTEDLY EXPIRED DUE TO ASYSTOLE. PRODUCT OVERHEATED FOR A PROLONGED TIME CAUSING SEVERE BODILY INJURIES. SUBSEQUENT INFO RECEIVED ADVISED CONSUMER, A DIABETIC, FELL ASLEEP WITH THE HEAT PAD ON HIS ANKLE CONTRARY TO INSTRUCTIONS. NO ADD'L INFO HAS BEEN RECEIVED. THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY. THE SURGEON NOTED FOUR HOLES IN BOWEL, WHICH WAS ATTRIBUTED TO THE USE OF THE DEVICE. CASE WAS CONVERTED TO AN OPEN PROCEDURE TO REPAIRL BOWEL. DEVICE SEPARATED FROM ANOTHER MFRS DEVICE DURING USE. THE PT REQUIRED TRANSFUSION TO REPLACE LOST BLOOD. FOLLOW UP WITH CUSTOMER ON 1/10/96 INDICATED THIS HAD OCCURRED ON FOUR OTHER OCCASIONS BUT CUSTOMER DID NOT PROVIDE ANY OTHER DETAILS. THE EVENT OCCURRED DURING A CHRONIC ELECTROPHYSIOLOGY STUDY CONDUCTED AS A RESULT OF A CHANGE IN PT DRUG THERAPY, WHICH COULD HAVE AN EFFECT ON DEVICE SENSING OR DEFIBRILLATION THRESHOLDS. DURING THE STUDY, INDUCED VENTRICULAR TACHYCARDIAS (VT) WERE SUCCESSFULLY TERMINATED 3 TIMES. ON THE FOURTH ATTEMPT, THE VT WAS NOT APPROPRIATELY SENSED, AND EXTERNAL CARDIOVERSION WAS DELIVERED AND SINUS RHYTHM WAS RESTORED. ON THE FIFTH ATTEMPT, THE DEVICE DELIVERED 10 EPISODES OF ANTITACHYCARDIA PACING AND FAILED TO TERMINATE THE ARRHYTHMIA. UNSUCCESSFUL ATTEMPTS BY MANUAL DEVICE INTERVENTION WERE MADE, RESULTING IN THE NEED FOR EXTERNAL DEFIBRILLATION. THE TOTAL DURATION OF THE ARRHYTHMIA WAS APPROX ONE MINUTE. THE DEFIBRILLATION WAS SUCCESSFUL, BUT T HE PT HAD DEVELOPED ELECTRICAL/MECHANICAL DISSOCIATION AND RESUSCITATIVE EFFORTS WERE INITIATED. DESPITE THESE EFFORTS THE PT COULD NOT BE REVIVED AND WAS PRONOUNCED DEAD. IMPLANT DURATION: 47 MOS. LVALO.kPT SAYS HE LEANED ON SIDERAIL AND IT GAVE WAY, HE FELL TO FLOOR. NO WITNESSES. PT RECEIVED SOME PARALYSIS. PT EXPIRED 1/4/96. BED TESTED BY SVC AND FOUND THAT SIDERAILS OPERATED PROPERLY, SIDERAIL OPERATION COVERED IN USER MANUAL. THE FEEDING TUBE WAS PLACED IN A PT. AN X-RAY REVEALED THAT THE TUBE WAS MISTAKENLY PLACED IN THE PT'S LUNG RATHER THAN IN THE STOMACH, AND A PNEUMOTHORAX RESULTED. THE DR REMOVED THE FEEDING TUBE AND ATTEMPTED TO PLACE A CHEST TUBE TO RELIEVE THE PN EUMOTHORAX. THE PT SUFFERED A CARDIAC ARREST AND DIED. AS A FOLLOW-UP TO A PT MAILING WHERE CO WAS INFORMED THAT THE PT HAD EXPIRED, A DEATH CERTIFICATE WAS REQUESTED. THE DEATH CERTIFICATE INDICATED THAT THE IMMEDIATE CAUSE OF DEATH WAS DUE TO MALIGNANT VENTRICULAR ARRHYTHMIA. NO OTHER INFO IS AVAILABLE AT THIST IME, AND THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PT'S OUTCOME. PT WAS ADMITTED FOR EXTRACTION OF THE ATRIAL LEAD DUE TO THE RECALL. USING STANDARD TECHNIQUE AND TRACTION WITH COUNTER TRACTION THE LEAD WAS WITHDRAWN INTACT WITH A SMALL PIECE OF ATRIAL MYOCARDIUM ATTACHED. DURING REPLACEMENT THROUGH THE TRANSVENOU S APPROACH, THE PT BECAME HYPOTENSIVE. FLUOROSCOPY WAS PERFORMED AND IT WAS NOTED THAT THE LEAD WAS OUTSIDE OF THE CARDIAC SILHOUETTE. A MEDIUM STERNOTOMY WAS MADE AND PERICARDIOTOMY PERFORMED. DISSECTION DISCLOSED THAT ONE OF THE ELECTRODES HAD PENE TRATED THE SUPERIOR VENA CAVA AND WAS INTO THE PLEURAL CAVITY. THE LEFT CHEST WAS OPENED AND A LARGE HEMOTHORAX WAS DISCOVERED. REPAIR OF THE SUPERIOR VENA CAVA WAS COMPLETED. THE PT STABILIZED AND WAS TRANSFERRED TO CSU. THE PT LATER DEVELOPED HYPOT ENSION WHICH PROGRESSED TO COMPLETE ELECTROMECHANICAL DISSOCIATION AND EXPIRED. THE PHYSICIANS FINAL DIAGNOSIS ON THE SUMMARY OF DEATH REPORT INDICATES: FAULTY PACEMAKER ELECTRODE, CARCINOMA OF THE BREAST, AND SICK SINUS SYNDROME. THE LEAD HAS NOT BE EN RETURNED FOR ANALYSIS. IMPLANT DURATION: 20 MONTHS. CORRECTIVE ACTION TAKEN: Z-209/211-5. ~kdYnXBPT SAYS HE LEANED ON 743277960105KAZ HEAT PADKAZKAZ MANUFACTURINGSERIOUS INJURYNINIPHYS MEDIRTP@WKJG?=;-   743273960104ENDOPATH STEATH ENDOSCOPIC/CONVENTIONAL CIRCULAR SETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIECS25GEN & PLASTIC SURGERYGAGP@zuseK?   743272960104ENDOPATH BABCOCK GRASPERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIBB10GEN & PLASTIC SURGERYGCJP@xwt_[YK1%   743271960105VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBCARDPACECARDIAC PACEMAKERS, INC.DEATH1625NACARDIOVASCULARLWSPW@|{xjhd_G?   743263960106HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJP@eYXUG@94   743262960105HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJF@eYXUG@94   743261960105HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 100090025CARDIOVASCULARMKJF@cWVSE@94   743259960105AMBULANCE COTFERNWASHFERNO-WASHINGTON, INC.SERIOUS INJURY35A35AGEN HOSPITALFPOF@h\[XLIF8"   743169960102NON PVC ULTRA-CONNECTOR WITH MALE LUER SLIPMEDEXMEDEX, INC.SERIOUS INJURYNAMX453-HGEN HOSPITALFPAF@{onk_XVH=8   743129960103COMPONENT CENTRAL MONITORHEWLPACKHEWLETT-PACKARD CO.DEATHM2350AM2350ACARDIOVASCULARDRTPX@pdc`RLFA.&   743064960102BREATHING FREQUENCY MONITORAEQUMEDIAEQUITRON MEDICAL, INC.DEATH9500ANESTHESIOLOGYFLSP@nba^PPLG0(   742869960104DOBBHOFF FEEDING TUBESHERMEDISHERWOOD MEDICAL CO.SERIOUS INJURYNA8881-710834GASTRO & UROLOGYFPDF6@ymliYNL>*"   742868960104CLEARTRACE ECG ELECTRODESCONMEDCONMED CORP.SERIOUS INJURYNA2700-001CARDIOVASCULARDRXF@nba^PHF8,&   742847960102CADENCE V-100 SERIES TIERED THERAPY DEFIBRILLATORVENTRITEXVENTRITEX, INC.DEATHV-100CV-100CCARDIOVASCULARLWSPe@yxuga[VG>   707843960216ACCUFIXTELEPACISYSTTELECTRONICS PACING SYSTEMS, INC.DEATH330-8010330801CARDIOVASCULARDTBPL@rfebTMFA   LVALkNZ8888PT PRESENTED WITH SHORTNESS OF BREATH AND COMPLAINTS OF GENERAL MALAISE. PT IN ATRIAL FIBRILLATION WITH ATRIAL THROMBOSIS NOTED ALONG LEAD. LAB FINDINGS REVEALED DIC. PT DEVELOPED PULMONARY EMBOLUS WITH PROGRESSIVE DYSPNEA, CONTINUED DETERIORATION LE ADING TO CARDIAC ARREST. POST MORTEM REVEALED LEFT MAIN AND RIGHT DISTAL ARTERIES WERE THROMBOSED. THE DEVICE WAS RETURNED FOR EVALUATION. DEVICE WAS APPLIED TO A 91-YR-OLD MALE WITH A CARDIAC HISTORY WHO WENT TO SLEEP AND DID NOT WAKE UP AND WAS IN CARDIAC ARREST. THE DEVICE PERFORMED ONE DEVICE ASSESSMENT THAT RESULTED IN A "NO SHOCK INDICATED" PROMPT. THE DEVICE THEN REPORTEDLY DISPL AYED "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECKED THE PADS AND CABLES, BUT THE PROMPTS WOULD NOT CLEAR. FIRE DEPT PERSONNEL ADMINISTERED CPR WHILE THE OPERATORS POWERED THE DEVICE OFF AND ON AGAIN 4-5 TIMES. THREE ADD'L DEVICE ASSESSMENTS WERE T HEN PERFORMED WHICH ALSO RESULTED IN NO SHOCKS INDICATED. THE CUSTOMER INDICATES THE PT'S RHYTHM WAS ASYSTOLE DURING THE 3 ASSESSMENTS. CPR WAS ADMINISTERED UNTIL AN ALS TEAM ARRIVED AND ASSUMED PT CARE. THE PT WAS PRONOUNCED ON SCENE VIA TELEMETRY. DEVICE WAS APPLIED TO A FEMALE PT IN CARDIAC ARREST. THE PT LATER EXPIRED. THE CUSTOMER STATED THAT ALTHOUGH HE DOES NOT BELIEVE THE DEVICE MALFUNCTIONED, THE VOLUNTEER PERSONNEL AT THE SCENE WHICH WAS RELATED TO THE PT THINKS THE DEVICE DID NOT SHOC K THE PT WHEN IT SHOULD HAVE. CUSTOMER CLAIMS THAT AS THEY WERE REMOVING THE COT FROM THE AMBULANCE, THE SAFETY U BAR DID NOT CONNECT WITH THE STOP BLOCK. AS A RESULT, THE COT FOLDED TO THE GROUND. THE PT WAS POSITIONED ON A BACKBOARD WITH HER HEAD EXTENDING BEYOND THE EDGE OF TH E COT. AS THE COT FOLDED TO THE GROUND, THE PT'S HEAD CONTACTED THE BUMPER. THE REPORT STATES THAT THE PT RECEIVED A 'GOOSE EGG' BUT NOTHING FURTHER. LVAL]g]STHE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. A CRACKING SOUND WAS HEARD BEFORE THE DEVICE WAS WITHIN FIRING RANGE. A SECOND DEVICE WAS INTRODUCED AND FIRED. SURGEON DID A LEAK TEST AND DISCOVERED LEAKAGE. SURGEON PROCEEDED IN CREATING A COLOS TOMY. PT, WHO HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DIED SUDDENLY ON DECEMBER 16, 1995. THE CAUSE OF THE DEATH WAS LISTED AS UNKNOWN: HOWEVER, THE FAX INDICATED THAT THERE WAS AN "ALLEGED MALFUNCTION OR PROBLEM". EPISODE DETAIL INDICATES 18 E PISODES OF FAST VENTRICULAR RHYTHM, LEADING TO SHOCK DELIVERY. HOWEVER, INPEDENCE MEASUREMENT INDICATE "OPEN CIRCUIT". A POST MORTEM EXAMINATION WAS NOT PERFORMED SO THE CONNECTION AND LEAD INTEGRITY WERE NOT VERIFIED. THE FAX INDICATED THAT THE LEAD S WERE IMPLANTED IN 1986, HOWEVER AN ATTEMPT TO OBTAIN ADD'L INFO ON THE LEAD, INCLUDING MODEL AND SERIAL NUMBERS, HAS BEEN UNSUCCESSFUL. ICD IMPLANTED-11/5/92. TOTAL IMPLANT TIME-37 MO. CO DOES NOT KNOW IF THE ICD WAS EXPLANTED OR BURIED WITH THE PT . INFO RECEIVED FROM FOREIGN COUNTRY STATED THAT THE ICD WILL NOT BE RETURNED TO CO FOR ANALYSIS. DURING AN INCIDENT CALL INVOLVING A 36 YR OLD MALE PT WITH A CARDIAC HISTORY WHO WAS IN CARDIAC ARREST, THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS AND DID NOT DISPLAY THE PT'S RHYTHM. THE PT WAS NOT OBESE AND HIS SKIN WAS NOT MOIST. T HE OPERATORS CHECKED THE PADS AND THE DEVICE, AND POWERED THE DEVICE OFF AND ON AGAIN; BUT THE PROMPTS WOULD NOT CLEAR. AN ALS TEAM THEN ARRIVED AND ASSUMED PT CARE. THE PT WAS TRANSPORTED TO A HOSP WHERE HE WAS PRONOUNCED. DURING TESTING BY THE CUST OMER BEFORE THE INCIDENT THE DEVICE FUNCTIONED PROPERLY. THE ELECTRODE PADS USED DURING THE INCIDENT WERE DISPOSED OF AT THIS HOSP AND ARE NOT AVAILABLE FOR EVALUATION. _y}t!z5 743315960110ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEZ35WGEN & PLASTIC SURGERYGAGF@"rmk]C7   743314960109ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIELC60GEN & PLASTIC SURGERYGAGF @"~idbT:.   743313960109ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEZ35WGEN & PLASTIC SURGERYGAGF@"rmk]C7   743312960105ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER RELOETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEVU35GEN & PLASTIC SURGERYGAGF@"wrpbH<   743311960105ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEZ45GGEN & PLASTIC SURGERYGAGF@"rmk]C7   743310960105PROXIMATE LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNITLC75GEN & PLASTIC SURGERYGAGF@"xwt_ZXJ0$   743309960111HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJF<@!eYXUG@94   743308960111HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 2000HS 2000CARDIOVASCULARMKJF@!eYXUG@94   743307960105DATASCOPE PERCOR STAT DL 9.5 FR T.W. IABDATASCOPEDATASCOPE CORP.DEATH0684-00-0255NACARDIOVASCULARDSPFm@!~rqn`^RM>5   743304960105CLEARTRACE CLEAR TAPE ADHESIVE GEL ELECTRODECONMEDCONMED CORP.SERIOUS INJURYNA1700-005CARDIOVASCULARDRXP@!utqc[YK?9   743302960105FLEXICAIRHILLROMHILL-ROM, INC.DEATHMC3 M-4000NAGEN HOSPITALFNLF@XLKH<:0+   743297960105WILSON SURGICAL FRAMEZIMMERPATIENT CARE DIV. ZIMMER, INC.SERIOUS INJURY551OPHTHALMICHRKF@qedaWTTF("   743296960105CAPSUREMEDTRONICMEDTRONIC, INC.DEATH4004NACARDIOVASCULARDTBF@UIHE751,   743279960105CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2700NACARDIOVASCULARLWRF/@sqmh@9  LVALy Zl%( Z( Z ǹr \Zl(Z(Z r DURING AN INCIDENT CALL, THE DEVICE WAS APPLIED TO AN 82-YR-OLD MALE PT IN CARDIAC ARREST WHO WAS FOUND SUPINE IN THE LOBBY OF A BUILDING. THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECK THE PADS AND CABLES, BUT THE PR OMPTS WOULD NOT CLEAR. A BACK-UP EMS TEAM ARRIVED AND APPLIED THEIR DEFIBRILLATOR TO THE PT. THIS DEVICE DISPLAYED "CHECK ELECTRODES" PROMPTS. THE DEVICE WAS REMOVED FROM THE PT AND CPR WAS ADMINISTERED UNTIL THE PT WAS TRANSPORTED TO THE HOSP. THE H OSP ER PERSONNEL ASSUMED PT CARE. THE PT EXPIRED LATER IN THE ER. DURING AN INCIDENT CALL INVOLVING A 62 YR OLD PT IN CARDIAC ARREST, FIRE DEPT PERSONNEL WERE ON SCENE WHEN THE EMS TEAM ARRIVED. THE EMS TEAM ASSUMED PT CARE AND APPLIED THE DEVICE. THE DEVICE DELIVERED FOUR SHOCKS TO THE PT. THE 4TH DEVICE ASSESSMEN T REPORTEDLY RESULTED IN "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECKED THE PADS, CABLES, AND ALL OTHER COMPONENTS OF THE DEFIBRILLATOR, BUT THE PROMPTS WOULD NOT CLEAR. OPERATORS CONTINUED TO ADMINISTER CPR WHILE TRANSPORTING THE PT TO A HOSP. TH E PT WAS NOT RESUSCITATED. THE PUMP "GAS LOSS ALARM" SOUNDED. NO BLOOD WAS NOTED IN THE CATHETER TUBING. THE PT THEN WENT INTO CARDIAC ARREST. AT THIS TIME, BLOOD WAS NOTED IN THE CATHETER TUBING. THE PT WENT ONTO EXPIRE. PT STATUS: EXPIRED RPT'D 1/3/96. THE PRODUCT IN THIS EV ENT WAS NOT RETURNED TO CO FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSP. THE FILE IS CONSIDERED CLOSED. ULCERATIONS FOUND UNDER THE ELECTRODE. NO FOLLOW-UP TREATMENT REQUIRED. SOURCE BELIEVES THAT THE CAUSE OF THE IRRITATION MAY BE DUE TO THE WAY THE PT IS BEING PREPPED. SHE DID INDICATE THAT SHE DID NOT KNOW IF THE ALCOHOL WAS BEING ALLOWED TO DRY THO ROUGHLY USED TO PREP THE PT'S SKIN PRIOR TO ELECTRODE APPLICATION. THE ABSENCE OF THOROUGH DRYING MAY HAVE CONTRIBUTED TO THIS PROBLEM. LVAL\[ x 707646960124GUARDIANTELEPACISYSTTELECTRONICS PACING SYSTEMS, INC.DEATH4210040004CARDIOVASCULARLWSP@ocb_QTHE PT REPORTEDLY EXPIRED DUE TO CARDIOGENIC SHOCK AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C005-10 AND 96-C006-12. THE VALVE WAS REPLACED DUE TO ALLEGED OUTLET STRUT FRACTURE. THE DEVICE WAS USED DURING A LEFT OOPHERECTOMY. THE DEVICE WOULD NOT FIRE ON THE THIRD FIRING. A SECOND DEVICE WAS FIRED, WHICH RESULTED IN MALFORMED STAPLES. IT WAS REPORTED THAT ONE DAY POSTOPERATIVELY, PT REQUIRED A REOPERATION FOR BLEEDING. THE DEVICE WAS USED DURING A LAPAROSCOPIC SIGMOID COLECTOMY. THE DEVICE WAS INSERTED THROUGH TROCAR AND APPLIED ON THE DISTAL RECTAL MARGIN AND FIRED; DEVICE WOULD NOT FIRE. SECOND ATTEMPT WITH FORCE APPLIED, WHICH RESULTED IN THE BREAKING OF HANDLE. A SECOND DEVICE WAS INTRODUCED AND FIRED WITHOUT DIFFICULTY. AFTER ANOTHER STAPLING DEVICE WAS TRANSANALLY INSERTED, IT WAS NOTED THAT THE RECTAL TISSUE BEYOND STAPLELINE WAS TORN AND SEVERELY DAMAGED. SURGEON CONVERTED TO AN OPEN PROCEDURE AND COMP LETED ANASTOMOSIS. THE DEVICE WAS USED DURING AN OVARIAN LIGAMENT PROCEDURE. THE DEVICE LOCKED ON TISSUE AND COULD NOT BE REMOVED. SURGEON CONVERTED TO AN OPEN PROCEDURE AND SURGICALLY REMOVED THE DEVICE FROM TISSUE. THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. ON THIRD FIRING TO COMPLETE TRANSECTION OF THE RECTUM, NO STAPLES WERE FORMED, WHICH RESULTED IN LEAKAGE. A TEMPORARY ILEOSTOMY WAS PERFORMED. THE DEVICE WAS USED DURING A V.A.T.S./LUNG BIOPSY. IT WAS REPORTED THAT SURGEON PLACED DEVICE WITHIN PLEURAL SPACE AND WAS UNABLE TO CLOSE IT ON LUNG TISSUE TO FIRE. SURGEON ELECTED TO EXTEND INCISION AND COMPLETE PROCEDURE WITH A COMPETITOR'S DEVICE . THE DEVICE WAS USED DURING A TRANSVERSE COLECTOMY. THE DEVICE "DID NOT FEEL EXACTLY RIGHT" UPON FIRING. POSTOPERATIVELY, THE PT DEVELOPED A LOW-OUTPUT FISTULA. tT&V=9A|vpjd^X 743435960110YALE-NEW HAVEN CUSTOM ANESTHESIA SETMEDEXMEDEX, INC.SERIOUS INJURYNAMX6349-1GEN HOSPITALFPAP@%uiheYQOA61   743434960106SHROUDED NEEDLE 20 GAMEDEXMEDEX, INC.SERIOUS INJURYNAMX920GEN HOSPITALFOZP@%cWVSGB@2'"   743423960105GEMINI V/N VENTED W/CHECKVALVE, 2 VERSASAFE INJECTIMEDIMED CORP.DEATHNA2120GEN HOSPITALFPAP,@%thgdXTRMC?   743408960110BREATHING FREQUENCY MONITORAEQUMEDIAEQUITRON MEDICAL, INC.DEATH9500NAANESTHESIOLOGYFLSP@%pdc`RPLG0(   743407960108BREATHING FREQUENCY MONITORAEQUMEDIAEQUITRON MEDICAL, INC.DEATH9500NAANESTHESIOLOGYFLSF]@$pdc`RPLG0(   743404960108CARPENTIER-EDWARDS BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2625DT6592CARDIOVASCULARLWRPy@$}|ykea\4-   743402960105EDWARDS-DUROMEDICS BILEAFLET PROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH3160NACARDIOVASCULARLWQP?@$|nlhc;4   743401960105CARPENTIER-EDWARDS PHYSIO RINGEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH4450NACARDIOVASCULARKRHP|@$wvsec_Z2+   743400960105CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2700NACARDIOVASCULARLWRP`@$sqmh@9   743399960105CARPENTIER-EDWARDS ANNULOPLASTY RINGEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH4500NACARDIOVASCULARKRHP@$}|ykie`81   743398960105CARPENTIER-EDWARDS BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH6625NACARDIOVASCULARLWRP@$yxugea\4-   743397960105CARPENTIER-EDWARDS BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2625NACARDIOVASCULARLWRP@"yxugea\4-   743372960111BLUE MAX BALLOON DILATATION CATHETERBOSTSCIEBOSTON SCIENTIFIC CORP.DEATHNA273065CARDIOVASCULARLITF@${onk]WUP91   743349960108BJORK-SHILEY CONVEXO-CONCAVE CARDIAC VALVE PROSTHESHILEYSHILEY, INC.DEATH29MBRCNICARDIOVASCULARLWQPA@"|pol^\VQE?  LVAL} SPATIENT REPORTS THAT SHE HAS WORN CONTACT LENSES FOR 2REPORT OF INFANT DEATH BY HOMECARE DEALER. TESTING BY MFR FOUND DEVICE FULLY FUNCTIONAL. THE PT REPORTEDLY EXPIRED DUE TO RIGHT HEART FAILURE, AORTIC DISSECTION AND DISSEMINATING INTERVASCULAR COAGULATION. THE PT REPORTEDLY EXPIRED DUE TO CONGESTIVE HEART FAILURE. THE PT REPORTEDLY EXPIRED DUE TO SEPSIS, PULMONARY PNEUMONIA, DISSEMINATED INTRAVASCULAR COAGULATION AND RENAL FAILURE. THE PT REPORTEDLY EXPIRED DUE TO MULTIPLE SYSTEM FAILURE SECONDARY TO LOW OUT-PUT SYNDROME. THE PT REPORTEDLY EXPIRED DUE TO CARDIOGENIC SHOCK AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C004-10 AND 96-C005-10. THE PT REPORTEDLY EXPIRED DUE TO CARDIOGENIC SHOCK AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C004-10 AND 96-C006-12. A BALLOON WAS USED TO FURTHER DILATE A NEWLY DEPLOYED STENT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. DURING WITHDRAWAL OF THE BALLOON CATHETER, IT IS BELIEVED THE BALLOON CAUGHT THE PROXIMAL END OF THE STENT CAUSING THE STENT TO SLIP OUT OF THE PORTAL VEIN. CONTINUAL ATTEMPTS TO RE-ADVANCE THE BALLOON AND STENT WERE UNSUCCESSFUL. THE BALLOON AND SHEATH WERE REMOVED. REPORTEDLY, THE STENT MIGRATED TO THE RIGHT ATRIUM. AN ATTEMPT TO SNARE THE STENT WAS IN PROCESS WHEN THE PT ARRESTED. RESUSCITATIVE MEASURES WERE UNSUCCESSFUL AND THE PT SUBSEQUENTLY EXPIRED. CO INVESTIGATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT CONTINUES. THE DEVICE WAS DESTROYED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. C O'S FOLLOW-UP INDICATED THIS DEVICE WAS BEING USED TO FURTHER DILATE A NEWLY DEPLOYED WALL STENT WITHIN THE PORTAL VEIN WHICH IS A NON-INDICATED USE OF THIS DEVICE. CO BELIEVES THIS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. LVALe9|vpjd^XRLF@:4.(" ztnhb\VPJD>82,& AN ARTICLE IN THE JOURNAL ARCH DERMATOL./VOL.131, JUNE 1995, (PAGE 707: CASE 1), REPORTED A 66-YEAR-OLD MALE BEING TREATED FOR A NEUROLOGICAL CONDITION DEVELOPED LEUKOCYTOCLASTIC VASCULITIS APPROX 24 HOURS AFTER THE THIRD COLUMN TREATMENT. THE RASH W AS ACCOMPANIED BY FEVER AND ARTHRALGIA IN BOTH KNEES. THERE WERE NO NEW NEUROLOGIC, RESPIRATORY, OR GASTROINTESTINAL SYMPTOMS. NO FURTHER IMMUNOADSORPTION THERAPY WAS GIVEN. THE ERUPTION DISAPPEARED AFTER APPROX 7 DAYS, AND THE PT WAS DISCHARGED. LAB ORATORY TESTS ON ADMISSION REVEALED NORMAL ELECTROLYTE LEVELS, A HEMATOCRIT OF 0.41, A WHITE BLOOD CELL COUNT OF 11.4X109/L, AND A PLATELET COUNT OF 260X109/L. THE RESULTS OF LIVER FUNCTION TESTS WERE NORMAL. URINALYSIS REVEALED A PH OF 5.5, WITH 20 TO 50 RED BLOOD CELLS PER HIGH-POWER FIELD: THE FINDINGS WERE OTHERWISE UNREMARKABLE. THE ERYTHROCYTE SEDIMENTATION RATE WAS 52MM/H. THE PT WAS DIAGNOSED AS HAVING COLON CARCINOMA 5 YRS PRIOR TO ADMISSION. A LOW ANTERIOR RESECTION REVEALED DUKES' B2 STAGE COLON CARCINOMA. THE PT RECEIVED FLUOROURACIL AND RADIATION THERAPY AFTER SURGERY. IN 1991, APPROX 4.5 YEARS AFTER SURGERY, HE BECAME ATAXIC. LOW-TITER ANTI-PURKINJE'S CELL ANTIBODIES WERE FOUND IN HIS SCUM SAMPLE AND WERE BELIEVED TO BE THE CA USE OF HIS NEUROLOGIC DEGENERATION. DEVICE NOT RETURNED TO MFR. (*). THE TUBING SEPARATED FROM THE STOPCOCK DURING USE. THE PT'S PORT HAD TO BE RE-ACCESSED AS A RESULT OF THE SEPARATION. NO ADD'L TREATMENT WAS NECESSARY. WHEN REMOVING THE SHROUDED NEEDLE FROM THE IV SITE, BLOOD SPLASHED INTO THE NURSE'S EYE. THE PT'S MOTHER TESTED POSITIVE FOR HEPATITIS C. NO TREATMENT WAS ADMINISTERED. NOT ENOUGH INFO AVAILABLE AT THIS TIME. REPORT OF INFANT DEATH BY HOMECARE DEALER. MONITOR REPORTEDLY NOT IN USE AT TIME OF EVENT. DEVICE IS BEING RETURNED TO MFR FOR EVALUATION AND TESTING. |sv  PT SAYS HE LEANED ON SIDERAIL AND IT GAVE WAY, HE FELL TO FLOOR. NO WITNESSES. PT RECEIVED SOME PARALYSIS. PT EXPIRED 743510960116HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS2000900000CARDIOVASCULARMKJF@*cWVSE?94   743509960116HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDFV@)j^]ZLF94   743508960116HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDF@)j^]ZLF94   743507960116HEARSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDF`@)i]\YKE83   743502960115GORE-TEX STRETCH VASCULAR GRAFTWLGOREW.L. GORE & ASSOCIATES, INC.DEATHNANIGASTRO & UROLOGYMCIPr@)wkjgWUSN2,   743467960108COMPAT ENTERAL FEEDING PUMPSANDNUTRSANDOZ NUTRITION CORP.DEATH199235199235GEN HOSPITALLZHP@(sgfcWQKF0(   743466960110ROLLS 2000INVACAREINVACARE CORP.SERIOUS INJURY2018AD780NAPHYS MEDIORP@(^RQNFD;-   743465960115SENSITIVE EYES DAILY CLEANERBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNINIOPHTHALMICLPNF@(j^]ZPNL>1)   743464960115SENSITIVE EYES PLUS SALINE SOLUTIONBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNINIOPHTHALMICLPNF@'qedaWUSE80   743463960110INTERPLAKBAUSLOMBBAUSCH & LOMB ORAL CARE ORGANIZATIONSERIOUS INJURYPB12NADENTALJEQF/@(l`_\VTPB   743461960109STORZ PREMIER MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT COMPANYSERIOUS INJURYDP2072NAOPHTHALMICHQEP@(sroec]O7/   743460960109STORZ PREMIERE MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT COMPANYSERIOUS INJURYDP1603 200NAOPHTHALMICHQEPz@'xwtjh^P80   743458960111INTRA-AORTIC BALLOON PUMPDATASCOPEDATASCOPE CORP.DEATHSYSTEM 97NACARDIOVASCULARDSPF0@'l`_\NLC>/&   743455960110BURDICK DEFIBRILLATOR/MONITOR/RECORDERBURDICKBURDICK, INC.DEATHMEDI 5NACARDIOVASCULARLDDP@'rfebTRLG:3   743436960108PROSORBA COLUMNIMREIMRE CORP.SERIOUS INJURYNA10GASTRO & UROLOGYLQQF,@%\POL<:8*   LVAL/YTP @ @ @ @743748MED DEVICE960111PALL CONSERVE HEAT & MOISTURE EXCHANGER WITH FLEXPALLBIOMPRODPALTHE PATIENT WAS TREATED FOR "CORNEAL ABRASION" FOLLOWING USE OF THE PRODUCT AS PART OF THE LENS CARE REGIMEN. THE TREATING PHYSICIAN WAS UNSURE OF THE CAUSE OF THE CONDITION. THE PRODUCT WAS NOT RETURNED FOR TESTING. DURING A CATARACT EXTRACTION PROCEDURE USING THIS OPHTHALMIC MICROSURGICAL SYSTEM, THE PHYSICIAN BROKE CAPSULE, PERFORMED A VITRECTOMY PROCEDURE, AND INSERTED AN ANTERIOR LENS. THE PHYSICIAN INDICATED THAT ASPIRATION SURGES FROM THIS SYSTEM MAY HAVE BEEN THE CAUSE FOR THE BROKEN CAPSULE AND THE SYSTEM WAS RETURNED FOR EVALUATION. THERE HAS BEEN NO REPORT OF ADD'L INJURY. THE UNIT DISPLAYED CONTINUOUS AUTOFILL FAILURE MESSAGES. THE PT EXPIRED. THE HOSP DOES NOT ATTRIBUTE THE DEATH OF THE PT TO THE PRODUCT. CO SVC ISOLATED AND REPLACED A DAMAGED PNEUMATIC MALE LUER FITTING. THE UNIT WAS TESTED TO FACTORY SPEC. IT FUNCT IONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. WHEN ATTEMPTING TO USE THE DEFIBRILLATOR ON A PT THE UNIT WOULD NOT CHARGE. IT WAS REPORTED THAT THE DR WAS PRESSING THE PEDAL DISCHARGE BUTTON WHILE THE NURSE WAS PRESSING THE CHARGE KEY ON THE UNIT. THE MESSAGE "SYSTEM ERROR" APPEARED ON THE DISPLA Y. ANOTHER DEFIBRILLATOR WAS IMMEDIATELY USED ON THE PT, PT DIED. THE CONTACT DECLINED TO GIVE OUT ANY FURTHER INFO ON THE PT OR THE EVENT. THE CONTACT DID NOT STATE THAT THE NEED TO USE ANOTHER DEFIBRILLATOR WAS RELATED TO THE DEATH OF THE PT. THE U NIT WAS REPORTEDLY TESTED BEFORE THE EVENT AND AFTER THE EVENT BY A THIRD PARTY SVC WITH NO PROBLEMS FOUND. THE "SYSTEM ERROR" APPEARED ON THE DISPLAY BECAUSE THE DR WAS PRESSING THE DISCHARGE BUTTON AT THE SAME TIME THE NURSE WAS PRESSING THE CHARGE KEY. THE TROUBLE SHOOTING GUIDE SECTION OF THE OPERATING INSTRUCTIONS MANUAL LISTED THIS ERROR MESSAGE AS A POSSIBLE RESULT OF THIS OPERATOR ERROR. THE DEVICE WILL NOT BE RETURNED TO THE FACTORY FOR FURTHER EVALUATION. LVALoYA 98-YR-OLD SEMI COMATOSE RESIDENT WITH HISTORY OF DEMENTIA AND STROKE DISCONNECTED THE ENTERAL FEEDING ADMINISTRATION SET FROM THE FEEDING PUMP. THE PUMP WAS OFF, THEREFORE ALL ALARMS WERE DISARMED, AND THE ROLLER CLAMP ON THE ADMINISTRATION SET TUB ING WAS IN THE FULL OPEN POSITION. APPROX 700 CC OF FORMULA WAS DELIVERED TO THE PT IN 1.5 HRS. THE PT REPORTEDLY SHOWED SIGNS OF ASPIRATION AND WAS TAKEN TO THE HOSP. THE PT DIED APPROX 12 HRS LATER. A USER RECEIVED A CUT TO THE LEFT CALF DUE TO A SHARP EDGE ON THE FRONT OF A MANUAL WHEELCHAIR. THE REPORT STATES THE USER REQUIRED STITCHES. THE PATIENT WAS TREATED FOR "BILATERAL CORNEAL ABRASIONS" FOLLOWING USE OF THE PRODUCT AS PART OF THE LENS CARE REGIMEN. THE TREATING PHYSICIAN WAS UNSURE OF THE CAUSE OF THE CONDITION. THE PRODUCT WAS NOT RETURNED FOR TESTING. WHILE USING THE ELECTRIC TOOTHBRUSH A TOOTH BROKE. MALE PT IS 68 YRS OLD. THE DEVICE CONSISTS OF 3 COMPONENTS: BRUSH HEAD, POWER HANDLE, AND CHARGER BASE. ONLY THE POWER HANDLE AND CHARGER BASE WERE RETURNED. THESE COMPONENTS PASSED VISUAL AND PERFOR MANCE TESTING. THE BRUSH HEAD WAS NOT RETURNED. A REPORT WAS RECEIVED THAT INDICATED THIS FACILITY ATTEMPTED TO USE ANOTHER MFR'S BIFURCATED INTRAOCULAR PRESSURE DRIP CHAMBER ADAPTOR IN CONJUNCTION WITH ADD'L ACCESSORY COMPONENTS, USING A LUER TO LUER ADAPTOR. THE IRRIGATION AND VITRECTOMY CUTTER PNEUMATIC DRIVER LINES WERE REVERSED CAUSING ASPIRATION WITHOUT CUTTING POWER WHEN THIS OPHTHALMIC MICROSURGICAL SYSTEM WAS ACTIVATED. THIS RESULTED IN A DETACHED RETINA. THERE HAS BEEN NO REPORT OF ADD'L PT INJURY AS A RESULT OF THIS OPERATOR ERROR. THE CONTACT FOR THIS FACILITY HAS INDICATED THAT THIS PARTICULAR TYPE OF ADAPTOR HAS BEEN USED PREVIOUSLY WITHOUT INCIDENT AND HAS INDICATED THAT THE EQUIPMENT DID NOT MALFUNCTION. THE PT INJURY WAS THE DIRECT RESULT OF OPERATOR ERROR. LVAL. YnXB 743277960105KAZ HEAT PADKAZKAZ MANUFACTURINGSERIOUS INJURYNINIPHYS MEDIRTP@WKJG?=;-   743273960104ENDOPDURING AN INCIDENT CALL, THE DEVICE WA NON-INVASIVE BLOOD PRESSURE READING WAS OBTAINED ON A PULSELESS PT DURING A CODE. PT EXPIRED. CAUSAL RELATIONSHIP OF DEVICE TO THIS INCIDENT IS UNDETERMINED. A CHECK OF THE SYSTEM BY SERVICE REP FOUND DEVICE OPERATING NORMALLY. DURING AN INCIDENT CALL INVOLVING A 67-YR-OLD MALE PT WEIGHING 300 LBS WHO WAS IN CARDIAC ARREST AND HAD BEEN DOWN APPROXIMATELY 15 MINUTES, A DEFIBRILLATOR WAS APPLIED USING ELECTRODE PADS. THE DEVICE WENT INTO THE MONITOR ONLY MODE. THE OPERATORS C HANGED THE PADS. THE PT WAS ASSESSED BY THE DEVICE AND WAS FOUND TO HAVE AN ASYSTOLIC RHYTHM. CPR WAS ADMINISTERED TO THE PT UNTIL AN ALS TEAM ARRIVED AND ASSUMED PT CARE. THE PT WAS TRANSPORTED TO A HOSP WHERE HE WAS PRONOUNCED. THE CUSTOMER STATED THAT THE DEVICE FUNCTIONED PROPERLY AND THAT HE BELIEVES THE FIRST SET OF PADS WERE NO GOOD. DURING AN INCIDENT CALL INVOLVING A 35-YR-OLD MALE PT IN CARDIAC ARREST, TWO SETS OF ELECTRODE PADS TORE WHEN THE OPERATORS ATTEMPTED TO REMOVE THE PROTECTIVE PLASTIC BACKING FROM THE PADS TO APPLY THEM TO THE PT. THE PT WAS TRANSPORTED TO A HOSP WHE RE HE EXPIRED. DURING AN INCIDENT CALL INVOLVING A 49-YR-OLD MALE PT IN CARDIAC ARREST, TWO SETS OF ELECTRODE PADS TORE WHEN THE OPERATORS ATTEMPTED TO REMOVED THE PROTECTIVE PLASTIC BACKING FROM THE PADS TO APPLY THEM TO THE PT. AN ALS TEAM THEN ARRIVED AND ASSUME D PT CARE WITH ANOTHER CO'S DEFIBRILLATOR. THE PT WAS TRANSPORTED TO A HOSP ER WHERE HE EXPIRED. THE GRAFT WAS PLACED IN THE LEG FOR ARTERIO-VENOUS ACCESS. A VCS CLIP SYSTEM WAS USED TO COMPLETE THE ANASTOMOSIS. TWELVE DAYS POSTOPERATIVELY, THE GRAFT REPORTEDLY TORE AT THE ANASTOMOSIS. THE PT REPORTEDLY DIED BECAUSE OF BLOOD LOSS. THE SURGEON DI D NOT IMPLICATE THE GRAFT AS THE CAUSATIVE FACTOR FOR THE PT DEATH, RATHER THE SURGEON IMPLICATED THE CLIP SYSTEM. LVAL:t!z5 743315960110ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNIEZ35WGEN & PLASTIC SURGERYGAGF@THE DEVICE DISCONNECTED FROM ANOTHER MFR DEVICE DURING ECMO TREATMENT. AS A RESULT, THE PT EXPERIENCED SOME BLOOD LOSS REQUIRING A TRANSFUSION. THERE WAS NO ADD'L TREATMENT NECESSARY. WHEN THE DEVICE WAS CONNECTED TO A PT IN FULL ARREST, THE DEVICE REPEATEDLY AND INAPPROPRIATELY INDICATED MOTION DETECTED. THE PT WAS NOT RESUSCITATED. THE PT REPORTEDLY EXPIRED; HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. THE PT REPORTEDLY EXPIRED DUE TO INTESTINAL NECROSIS DUE TO LOW CARDIAC OUTPUT. THE PT WAS INSTRUMENTED ON 6/23/94 WITH RODS AND RETURNED FOR REMOVAL OF FRACTURED ROD 12/19/95. AT EXPLANTATION, PT NOTED TO HAVE A SOLID FUSION. MALE PT IS 58 YRS OLD. DEVICE NOT RETURNED TO MFR. ON 1/9/96 PT HAD PTCA PROCEDURE. HEMOSTASIS WAS ACHIEVED WITH CO'S DEVICE WITHOUT COMPLICATION. LATER THAT EVENING PT REPORTED TINGLING AND NUMBNESS IN THE VASCULAR HEMOSTASIS LEG. PT HAD A PULSE IN THE FOOT BUT BLOOD PRESSURE AND HEART RATE HAD DROP PED. PT WAS PUT ON A VENTILATOR. PHYSICIAN FELT THAT THESE COMPLICATIONS RESULTED FROM A RETROPERITONEAL BLEED CAUSED BY A DOUBLE WALL PUNCTURE. ON FOLLOW-UP (1/11/96) THE PT DIED. UNCONFIRMED CAUSE OF DEATH PER PHYSICIAN IS AN INFARCT. DURING AN INCIDENT CALL, THE DEVICE WAS APPLIED TO A 60-YR-OLD FEMALE PT WITH A HISTORY OF CARDIAC, EMPHYSEMA, ASTHMA, AND DIABETES WHO WAS IN CARDIAC ARREST. THE DEVICE REPORTEDLY DISPLAYED THE PT'S RHYTHM AS VENTRICULAR FIBRILLATION AND "CHECK ELEC TRODE" PROMPTS. THE OPERATORS CHECKED THE PADS AND CABLES, AND CHANGED THE PADS AND BATTERY, BUT THE PROMPTS WOULD NOT CLEAR. THE PT WAS NOT RESUSCITATED. DURING TESTING BY THE CUSTOMER AFTER THE INCIDENT, THE DEVICE REPORTEDLY AGAIN DISPLAYED "CHECK ELECTRODES" PROMPTS. 1`^v\#3W743402MED DEVICE960105EDWARDS-DUROMEDICS 743958960116FIRST CHOICE BLOOD GLUCOSE REAGENT TEST STRIPSPOLYTECHCPOLYMER TECHNOLOGY INTERNATIONALSERIOUS INJURY91070CLINICAL CHEMISTRYCFRP @0wrrdD;   743914960112SWAN-GANZ THERMODILUTION ATRIO-VENTRICULAR PACEPOREDWACVSEDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP.DEATH93A-991H-8F93A-991H-8FCARDIOVASCULARDYGP@0}xF?   743894960112PROVIDER ONEABBOLABOABBOTT LABORATORIESDEATHNA13905 04 04GEN HOSPITALFRNF@/bVURF;94!   743878960114LIFEPAK AUTOMATIC ADVISORY DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.DEATH300804900-03CARDIOVASCULARMKJP@*tspbYVQ=5   743868960115SIDERAILHILLROMHILL-ROM CO.DEATH301P301GEN HOSPITALFNLP@.PDC@40-(   743851960112CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH6625LPNACARDIOVASCULARLWRP@*rpje=6   743846960112CARPENTIER-EDWARDS ANNULOPLASTY RINGEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH4400NACARDIOVASCULARKRHPT@*}|ykie`81   743748960111PALL CONSERVE HEAT & MOISTURE EXCHANGER WITH FLEXPALLBIOMPRODPALL BIOMEDICAL PRODUCTS CO.SERIOUS INJURYHME1522FNAANESTHESIOLOGYBYDF@.~|tfJ>   743747960110VANTAGECOOPERVISIONCOOPERVISION, INC.SERIOUS INJURYNANAOPHTHALMICLPLPb@-^RQNDB@2    743744960109ISOLA 1/4" RODACROMEDACROMED CORP.SERIOUS INJURYNAUNKORTHOPEDICJDNP@*\POLB?=/"   743681960111LIFEPAK DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.DEATH59-00285-08CARDIOVASCULARLDDP@-l`_\NDC>*"   743583960109TRAMSCOPE PATIENT MONITORMARQELECMARQUETTE ELECTRONICS, INC.DEATHNANACARDIOVASCULARDRTF@)pdc`RPNI.&   743546960111COBE CENTRYSYSTEM 2COBERENACARECOBE RENAL CARE, INC.DEATHNA018701-002GASTRO & UROLOGYFIIF@,rfebRHFA,   743513960112VASOSEAL VASCULAR HEMOSTASIS DEVICEDATASCOPECOLLAGEN PRODUCTS DIV. DATASCOPE CORP.DEATHNA75301GEN & PLASTIC SURGERYLMFF@*kfd_90  LVALZ(]:'743465MED DEVICE960115SENSITIVE EYES DAILY CLEANERBAUSLOMBBAUSCH & LOMBSERIOUS INJURYNINIOPHTHALMICLPNF@)tthgdZXVH;3743464MED DEVICE960115SENSITIVE EYES PLUS SALINE NURSING HOME EMPLOYEE CLAIMS GEL MATTRESS LEAKED GEL SUBSTANCE ON FLOOR; WHEN PT GOT OUT OF BED SHE SLIPPED ON THE GEL AND FELL, BREAKING HER LEG. FEMALE PT'S AGE IS 70-80, WT 130-140. THE DEVICE DISCONNECTED FROM ANOTHER MFR'S DEVICE DURING ECMO TREATMENT. AS A RESULT, THE PT EXPERIENCED SOME BLOOD LOSS REQUIRING A TRANSFUSION. THERE WAS NO ADD'L TREATMENT NECESSARY. DURING A DIALYSIS TREATMENT, THERE WAS A PT DEATH AFTER THE DIALYSIS WITH STRAIGHT ACID CONCENTRATE. AN AUTOPSY WAS PERFORMED ON THE PT AND IT WAS FOUND A MYOCARDIAL INFARCTION WAS THE CAUSE OF DEATH. ANALYSIS: ACID ALONE WAS USED IN THE MACHINE AND THAT PRE-DIALYSIS CHECKS WERE NOT PERFORMED. THIS RESULTS IN METABOLIC ACIDOSIS DURING DIALYSIS BECAUSE NO BASE REPLACEMENT (BICARBONATE) IS ADMINISTERED DURING DIALYSIS. THIS ANALYSIS WAS CONFIRMED BY THE INVESTIGATOR FOR THE STATE DEPT OF HEALTH. R ECORDS REGARDING TREATMENTS, MACHINES USED, AND STAFF PRESENT WAS NOT AVAILABLE BECAUSE THESE RECORDS WERE REMOVED PRIOR TO THE INVESTIGATION BY THE STATE. THE OPERATOR MANUAL SPECIFICALLY WARNS THE OPERATOR NOT TO USE ACID CONCENTRATE IN THE MACHINE . ALTHOUGH THE CONDUCTIVITY FOR ACID OR ACETATE IS SIMILAR FOR CONDUCTIVITY MONITORING, THE OPERATOR MUST VERIFY THE CONDUCTIVITY AND PH OF THE CONCENTRATE PRIOR TO BEGINNING OF TREATMENT. THE PH MUST BE IN THE RANGE OF 6.5-8.0. IF THE PH IS INCORREC T, THE OPERATOR IS ADDITIONALLY PROMPTED TO VERIFY THAT THE CORRECT CONCENTRATE SOLUTION IS USED. THE PH OF THE ACID MIXED IN THE MACHINE IS APPROX 4.0 WHICH IS LOWER THAN THAT OF ACETATE, WHICH IS 6.0-8.0 AND WOULD BE DETECTED BY THE OPERATOR WHEN T HIS VERIFICATION STEP IS PERFORMED. BASED ON CONVERSATIONS WITH THE INVESTIGATOR, THIS WAS UNDOUBTEDLY OPERATOR ERROR THAT CAUSED THE DEATH. NO ADD'L CORRECTIVE ACTION BY CO IS ANTICIPATED. LVAL@\V=9A 743435960110YALE-NEW HAVEN CUSTOM ANESTHESIA SETMEDEXMEDEX, INC.SERIOUS INJURYNAMX6349-1GEN HOSPITALFPAP@uiheYQOA61   743434960106SHROUDED NEEDLETHE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE 1ST CLIP HUNG UP ON TISSUE AND THE SECOND CLIP SEVERED THE CYSTIC ARTERY. SURGEON CONVERTED TO AN OPEN PROCEDURE TO COMPLETE CASE. THE FRONT CASTER OF A MANUAL WHEELCHAIR BROKE. THE REPORT STATES THE USER FELL, ALLEGEDLY SUSTAINING A BROKEN KNEE. RECORDS INDICATE THE WHEELCHAIR INVOLVED IS OVER 8 YRS OLD. PT HAD ELEVEN EPISODES OF VT AND THREE EPISODES OF VG. PT EXPIRED. THE DEVICE(S) WAS (WERE) RETURNED RETURNED FOR EVALUATION. PT WAS DISPENSED NEW SOFT CONTACT LENSES ON 11/29/95. PT WAS TREATED FOR AN ULCER OF THE LEFT EYE AT THE ER OF A LOCAL HOSP ON 12/25. THE ER PHYSICIAN HAD PRESCRIBED AN ANTIBIOTIC MEDICATION AND INSTRUCTED PT TO FOLLOW UP WITH AN EYE CARE PRACTITIONE R. PT WAS SEEN BY THE OPTOMETRIST ON 12/26/95. THE OD REPORTED THE ULCER WAS RESOLVING AND A MILD KERATITIS WAS ALSO NOTED. THE OD PRESCRIBED A LUBRICATING AGENT TO BE USED IN CONJUNCTION WITH THE ANTIBIOTIC MEDICATION. PT'S CONDITION HAS RESOLVED WI TH OUT COMPLICATION AND A NEW LENS HAS BEEN ORDERED. MALE PT IS 43 YRS OLD. DEVICE NOT RETURNED TO MFR. A LONG TERM FACILITY PT, WITH A HISTORY OF CARDIAC DISEASE, WAS CONNECTED TO THE DEVICE IN A DEFIBRILLATION ATTEMPT. THE PHYSICIAN PRESSED THE PADDLE CHARGE BUTTON, THE DEVICE CHARGED AND DELIVERED ENERGY TO THE PT. THE PHYSICIAN ALLEGED THE DEVICE D ID NOT DELIVER SELECTED DEFIBRILLATOR ENERGY TO THE PT. THIS ALLEGATION WAS BASED UPON A LACK OF EXPECTED PT DEFIBRILLATION AND AN OBSERVATION THAT THE DEVICE DID EMIT LOUD ENOUGH SOUNDS DURING CHARGE AND DISCHARGE. NO ADD'L DETAILS CONCERNING THE EV ENT WERE REPORTED. THE PT WAS NOT RESUSCITATED. SUBSEQUENT TO THE EVENT THE DEPT HEAD DISCHARGED THE DEVICE REPEATEDLY INTO A BATTERY SUPPORT SYSTEM AND OBSERVED THE DELIVERY OF SPECIFIED ENERGIES. ~LVALBVTHE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A PT'S DEATH. ADD'L INFO REGARDING THE REPORTED EVENT HAS NOT YET BEEN MADE AVAILABLE. HOSP ALLEGES ARC OCCURRED, RESULTING IN PT BURN IN AND AROUND PT'S MOUTH. BURNS WERE FIRST AND SECOND DEGREE. THE MAINFRAME OF THE COT BROKE AS THE COT WAS BEING UNLOADED FROM THE VEHICLE. THE REPORT FURTHER STATES THAT THE ATTENDANTS SUSTAINED A CERVICAL STRAIN AND A SHOULDER STRAIN. THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IT WAS REPORTED THAT POSTOPERATIVELY, THE PT'S HEMOGLOBIN AND BLOOD PRESSURE DROPPED. PT RECEIVED TRANSFUSION OF 4 UNITS OF BLOOD. AN 82-YR-OLD FEMALE RESIDENT WAS FOUND WITH HER BODY BETWEEN THE TWO SIDERAILS. HER CHIN WAS RESTING ON TOP OF THE UPPER RAIL AND HER BOTTOM WAS 1 INCH OFF THE FLOOR. PT WAS IN RESTRAINTS AND PT HAD EXPIRED. MEDICAL EXAMINER RULED DEATH BY ASPHYXIATI ON. SURGEON IN AN ADJACENT OPERATING ROOM OPENED THE DEVICE'S UNIT PACKAGE AND REMOVED THE EXTENSION (FLEX TUBE). IN THE OPERATING ROOM WHERE THE DEVICE WAS TO BE USED, THE ANESTHESIA CIRCUIT AND MACHINE WERE CHECKED FOR PRESSURE AND LEAKS. THE DEVICE WA S SUBSEQUENTLY INSTALLED IN THE INSPIRATORY PORT OF THE MACHINE, NO PRESSURE OR LEAK TEST WAS THEN PERFORMED. IT WAS OBSERVED THAT THE PT WAS NOT BEING VENTILATED. THE DEVICE WAS REMOVED FROM THE CIRCUIT. THE PT CONTINUED NOT TO BE VENTILATED, AND WA S MANUALLY VENTILATED, AND EXUBATED. IT WAS NOTICED THAT THE OBSTRUCTION TO VENTILATION WAS A CAP, (WHICH IS SUPPLIED IN THE UNIT PACKAGE, TO BE USED TO COVER THE OPENING OF THE FLEX TUBE) LODGED IN THE MACHINE'S INSPIRATORY PORT. IT WAS SURMISED THA T THE CAP WAS CARRIED ALONG WITH THE DEVICE TO INSPIRATORY PORT WHERE IT BECAME LODGED DURING THE INSTALLATION OF THE DEVICE. THE PHYSICIAN SUGGESTED THAT THE DEVICE MAY HAVE BEEN MANIPULATED WHILE RESTING ON THE ANESTHESIA MACHINE PRIOR TO USE. LVALj.V=9THE DEVICE WAS USED DURING A THORACOTOMY. POSTOPERATIVELY, THE PT DEVELOPED AN AIR LEAK. PT HAS REQUIRED EXTENDED HOSPITALIZATION FOR OBSERVATION. THE FRONT CASTER OF A MANUAL WHEELCHAIR BROKE. THE REPORT STATES THE USER FELL, SUSTAINING A DISPLACED NASAL SEPTAL FRACTURE. RECORDS INDICATE THE WHEELCHAIR INVOLVED IS OVER TEN (10) YRS OLD. CUSTOMER WAS UNABLE TO REMOVE PEG TUBE FROM PT. THE PT IS SCHEDULED FOR AN ESOPHAGOL GASTRO DUODENOSCOPY (EGD) UNDER GENERAL ANESTHESIA FOR REMOVAL OF THE GASTROSTOMY TUBE. NO FURTHER INFO OR COMPLICATIONS REPORTED. POST-MORTEM EXAMINATION REVEALED A STRUT FRACTURE OF A SIZE 33 MITRAL 60 DEGREE CONVEXO-CONCAVE HEART VALVE. THE VALVE SERIAL NUMBER WAS NOT PROVIDED. OVERDELIVERY OF DOBUTAMINE DUE TO USER MISPROGRAMMING REPORTED. THE PT WAS A 13-YR-OLD GIRL (DOB 2/6/82) WITH A HISTORY OF AIDS AND SEVERE WASTING. THE PUMP WAS TO BE SET TO INFUSE DOBUTAMINE 274 MG IN 100 ML OF D5W OVER APPROX 4 DAYS (99 HRS). THE P UMP WAS INADVERTENTLY SET FOR A DELIVERY PERIOD OF "4.0:0" WHICH IS 4 HRS, NOT 4 DAYS. THE OVERDELIVERY OCCURRED FROM 6:30 PM TO 10:30 PM. THE HOME HEALTH AGENCY WAS NOTIFIED AND A NURSE ARRIVED TO ASSESS THE PT. SHE HAD NO ADVERSE SYMPTOMS AND HER V ITAL SIGNS WERE STABLE. HER DR FELT SHE COULD BE MONITORED AT HOME. AT 4:15 AM SHE WOKE UP FEELING "RESTLESS". HER DR FELT SHE MIGHT BE VOLUME OVERLOADED (SHE ALSO RECEIVES TPN) AND HAD HER BROUGHT TO THE ER. CARDIOLOGY ASSESSMENT, INCLUDING EKG AND ECHOCARDIOGRAM, WAS NORMAL FOR HER CONDITION. SHE WAS SENT HOME BY 7:30 AM. THERE WERE NO SYMPTOMS OF ANY ADVERSE REACTION AND THE DOBUTAMINE WAS RESTARTED. SHE WAS READMITTED TO THE HOSP ON 1/7/96 FOR "DISEASE PROGRESSION"AND SHE EXPIRED LATE THAT N IGHT. THE CAUSE OF DEATH WAS DETERMINED TO BE DUE TO HER "DISEASE PROCESS". PHYSICIANS DID NOT FEEL THE DOBUTAMINE OVERDELIVERYCONTRIBUTED. NO ADD'L INFO IS AVAILABLE. \LVAL3*loA PT WITH TERMINAL CANCER DIED 30 TO 45 MINUTES AFTER THE DEVICE WAS INSERTED. THE NURSE THINKS THE PT DIED OF A PULMONARY EMBOLISM. THE NURSE DID NOT ATTRIBUTE THE DEATH TO THE DEVICE. THE END USER REPORTED THE FOLLOWING: 11/22/95 AT 8:00 AM THE USER'S BG RESULT WAS 75 MG/DL FOLLOWED BY A "NOT OK" METER MESSAGE. AFTER WIPING THE OUTSIDE OF THE METER (NOT METER OPTICS) THE USER OBTAINED A RESULT OF 65 MG/DL. USER THEN CONSUMED ORANG E JUICE AND SUGAR. THE USER STATED SHE BEGAN TO EXPERIENCE "CHEST PAINS" AND WAS TRANSPORTED PRIVATELY TO THE HOSP. AT APPROX 8:20 AM A LAB BG RESULT OF 609 MG/DL WAS OBTAINED. THE USER WAS SUBSEQUENTLY ADMITTED, TREATED WITH INSULIN IV AND RELEASED TWO DAYS LATER. "ON OR ABOUT 5/27/94, PLAINTIFF'S DECEDENT WAS DIAGNOSED AS SUFFERING FROM CORONARY ARTERY DISEASE. ALTHOUG PLAINTIFF'S DECEDENT UNDERWENT SEVERAL ANGIOPLASTIES, THESE DID NOT RELIEVE PLAINTIFF'S DECEDENT'S CORONARY ARTERY DISEASE AND PLAINTIFF'S DEC EDENT CONTINUED TO SUFFER CHEST PAIN. ON OR ABOUT 10/11/94, PLAINTIFF'S DECEDENT UNDERWENT OPEN HEART SURGERY IN AN ATTEMPT TO CORRECT HIS CORONARY ARTERY DISEASE. DURING SURGERY, CHEST TUBE ATTACHED TO THE DEFENDENT MFR'S AUTOTRANSFUSION SYSTEM WERE INSERTED. CENTRAL VENOUS LINES WERE ALSO INSERTED THROUGH THE DEFENDANT MFR'S SHEATH INTRODUCER. THE DEFENDANT NURSES CARED FOR PLAINTIFF'S DECENDENT POST OPERATIVELY AND WERE RESPONSIBLE FOR THE PROPER MAINTENANCE AND FUNCTIONING OF THESE TUBES AND LINES. SHORTLY AFTER SURGERY, PLAINTIFF'S DECEDENT BEGAN TO HEMORRHAGE, AND ALTHOUGH THE HEMORRHAGING SUBSIDED, PLAINTIFF'S DECEDENT SUFFERED A CARDIAC ARREST. WHILE PERFORMING CARDIOPULMONARY RESUSCITATION, PLAINTIFF'S DECEDENT'S PHYSICIANS DISCOVE RED A VAST AMOUNT OF AIR IN PLAINTIFF'S DECEDENT'S HEART. ALTHOUGH PLAINTIFF'S DECEDENT WAS DIAGNOSED AS SUFFERING FROM MASSIVE AIR EMBOLISM, HE WAS UNABLE TO BE RESUSCITATED, AND EXPIRED DUE TO THE MASSIVE AIR EMBOLISM." LVAL~2i707644MED DEVICE960111OPTIMA MPT SERIES IITELEPACISYSTTELECTRONICSAN INTRA-AORTIC BALLOON CATHETER RUPTURED 3 DAYS AFTER PLACEMENT FOLLOWING A CABG X 3 PROCEDURE. THE PT SUBSEQUENTLY EXPIRED. THE PT WAS CONSIDERED TERMINAL PRIOR TO BALLOON RUPTURE. AN AUTOPSY REVEALED LOW CARDIAC OUTPUT AND RENAL FAILURE WERE THE C AUSE OF DEATH. CO'S INVESTIGATION INTO THE CIRCUMSTANCES SURROUNDING THIS EVENT CONTINUES. PT WAS OPERATED ON FOR A LYMPHANGIOMA. A TENSOR BANDAGE WAS USED POST-SURGERY FOLLOWED BY THE STOCKINGS. PT ALLEGEDLY DEVELOPED CELLULITIS THE FIRST DAY HE WORE THE STOCKING. CONDITION SUBSIDED AFTER ADMINISTRATION OF ANTIBIOTICS. DR COULDN'T SAY WHA T ROLE, IF ANY, THE STOCKINGS PLAYED IN DEVELOPMENT OF CELLULITIS. PT IS NOT USING ANY COMPRESSION THERAPY AT THIS TIME. AFTER CORONARY INJECTIONS HAD BEEN COMPLETED, THE PT WENT INTO V-TACH AND WAS DEFIBRILLATED 2 TIMES AT 200 W/S WITH CONVERSION. THE PT REMAINED UNSTABLE WITH REPEATED DETERIORATION OF RHYTHM AND SUBSEQUENT DEFIBRILLATIONS. THE PHYSICIAN INSERTED AN I AB CATHETER. ATTENDING RNS STATED THAT THE CATHETER WOULD NOT AUGMENT. THE GAS LINE WAS CHECKED FOR LEAKS AND NONE WERE FOUND. THE PHYSICIAN STATED THAT THERE WAS SOME BLOOD AT THE SITE OF THE CATHETER DISTAL END. THE BALLOON WAS SEEN TO INFLATE ONCE OR TWICE BUT NO MORE. THE PT EXPIRED. ADD'L INFO RECEIVED FROM THE HOSP INDICATED THE BALLOON, WHICH WAS MFG BY ANOTHER CO WAS DEFECTIVE AND DID NOT PROPERLY INFLATE. THE IAB PUMP IS NOT THOUGHT TO BE DEFECTIVE BUT WILL BE RETURNED FOR THOROUGH FUNC TIONAL TESTING. THE UNIT'S OPERATING MANUAL INDICATES A LEAK IN THE BALLOON LINE WILL SOUND THE "GAS LEAKAGE" ALARM. IN THIS CASE THE DEFECTIVE BALLOON APPEARS TO BE PERFORATED ALLOWING BLOOD TO ENTER CATHETER. UNIT IS DESIGNED TO DETECT LEAK IN BALL OON LINE AND SOUND "GAS LEAKAGE" ALARM IF PUMP IS IN "AUTO" MODE. IN THIS CASE IT WAS NOT REPORTED IF THE UNIT WAS IN THE "MANUAL" OR "AUTO" MODE. /dV=FD6BWZ,r*WՉ)82,& AN INTRA-AOR744434MED DEVICE960123CLEARTRACE ECG ELECTRODECONMEDCONMED CORP.SERIOUS INJURYNA1700-030CARDIOVASCULARDRXP@=wwkjgYQOA5/744433MED DEVICE960122CLEARTRACE ECG ELECTRODECONMEDCONMED CORP.SERIOUS INJURYNA1700-030CARDIOVASCULARDRXP@<wwkjgYQOA5/744427MED DEVICE960123HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDPQ@?tthgdVPC>)!744412MED DEVICE960123ROLLS 1000INVACAREINVACARE CORP.SERIOUS INJURY1018SA180NAPHYS MEDIORP@;hh\[XPNE7)!744400MED DEVICE960122SHERIDAN/CF TRACHEAL TUBEKENDALLKENDALL HEALTHCARE PRODUCTS DIV. KENDALL CO.DEATHNA5-10120ANESTHESIOLOGYBTRP@=qjhc70744399MED DEVICE960122VSP BONE PLATES AND BONE SCREWSACROMEDACROMED CORP.SERIOUS INJURYNA6.25 X 40 MM 2025-01ORTHOPEDICJDNP@:|{xnZXJ=6744347MED DEVICE960119PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVEJOHNJOHNPRODJOHNSON & JOHNSON INTERVENTIONAL SYSTEMS CO.DEATHPS1535 (X2)CARDIOVASCULARMAFPK@>UI744330MED DEVICE960122HYDRADJUST IV UROLOGICAL TABLELIEBFLARLIEBEL-FLARSHEIM CO.SERIOUS INJURYNA400002RADIOLOGYKXJP@>tspga_Q=5744314MED DEVICE960119CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH6625LPNACARDIOVASCULARLWRP@:|ztoG@744313MED DEVICE960119CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH2700NACARDIOVASCULARLWRP@>}{wrJC744312MED DEVICE960119CARPENTIER-EDWARDS DURAFLEX BIOPROTHESISEDWACVSEDWARDS CVS DIV. BAXTER HEALTHCARE CORP.DEATH6625LPNACARDIOVASCULARLWRP@>{ysnF?744305MED DEVICE960118FIRST MEDIC SEMI-AUTOMATIC DEFIBRINGERS AND VENTILATOR DEPENDENT. 12/6/95-COMATOSE STATE. EXPLANTED 12/10/95. DEVICE NOT RETURNED TO MFR.jLVALz/  r`PATIENT CLPATIENT RECEIVED LENSES AND ONE WEEK LATER RETURNED STATING THAT IT FELT LITHE DEVICE HAD BEEN RETURNED TO HOSP FROM A LOCAL FUNERAL HOME. THE DEVICE(S) WAS (WERE) RETURNED FOR EVALUATION. ANALYSIS OF THE LEAD REVEALED A SEPARATION IN THE INSULATION MATERIAL. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED, THE CAUSE O F DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. CAUSE OF DEATH HAS BEEN REQUESTED. AN INCREASE OF BILIRUBIN WAS OBSERVED IN THE PT'S BLOOD. MD TESTED THE BLOOD IN THE TRANSFUSION SET BEFORE AND AFTER DEVICE. THE BLOOD BEFORE DEVICE WAS MORE HEMOLYZED THAN THE BLOOD AFTER DEVICE. MD FELT NEGATIVE PRESSURE WAS THE CAUSE OF HEMOLYSIS BETWEEN THE FILTER AND THE SYRINGE USED TO MAKE THE TRANSFUSION, DUE TO THE DEVICE BEING BLOCKED. THE BLOOD USED WAS LPRC (LEUKOCYTE POOR RED CELL) AND WAS IRRADIATED AT 15 GY. THE MD SAID THE BLOOD WAS HANDLED NORMALLY OTHERWISE. DURING THE CODE SITUATION AND WHILE ATTEMPTING TO DELIVER A VASOACTIVE DRUG, HOSP SPENT APPROX 30 MINS TRYING TO GET INFUSION SET AND INFUSION PUMP TO WORK. PT EXPERIENCED A PULMONARY EMBOLI AND EXPIRED. REPORTER WAS NOT AT LIBERTY TO RELEASE ANY INF O CONCERNING THE DETAILS OF THE INCIDENT OR MORE PT INFO. EXACT FREQUENCY OF THE EVENT IS UNKNOWN. IT IS UNCLEAR AT THIS TIME THAT DETAILS WOULD BE COMING FROM REPORTER. AN EMPLOYEE OF ANOTHER CO INFORMED MFR OF THE POSSIBILITY OF AN INCIDENT INVOLVI NG A DEATH ON 1/5/96. CO CALLED CO ON 1/8/96. CO HAD NOT HEARD ANY FURTHER DETAILS. HOSP WAS CALLED ON 1/8/96, AND CO SPOKE TO DIRECTOR OF PURCHASING. SHE COULD NOT REVEAL ANY DETAILS. RISK MANAGER STATED THERE WAS NO DEATH INVOLVING THE EQUIPMENT. M EDWACTH REPORT WAS RECEIVED FROM THE OTHER CO ON 1/12/96 INDICATING A DEATH REPORT HAS BEEN FILED. RISK MANAGER WAS CONTACTED ON 1/15/96. SHE STATED THAT THE INFO COULD NOT BE VERIFIED. THE PUMP WAS A SOURCE OF FRUSTRATION BUT IT CAN'T BE DETERMINED IF IT CONTRIBUTED TO THE DEATH. INVESTIGATION AND OUTCOME CAN'T BE CONCLUDED AT THIS TIME. LVALr\#3W 743958960116FIRST CHOICE BLOOD GLUCOSE REAGENT TEST STRIPSPOLYTECHCPOLYMER TECHNOLSTAFF MEMBERS WERE TREATING A PT DURTHIS PT HAD ANOTHER STENT IMPLANTED IN 11/95. TWO FISTULAS DEVELOPED AND THIS DEVICE WAS IMPLANTED AND THE FISTULAS WERE BEING COVERED. THIS DEVICE WAS IMPLANTED ON 1/9/96 WITH NO COMPLICATIONS NOTED. ON 1/10/96 THE PT WAS SPITTING UP BLOOD. WITHIN A SHORT PERIOD OF TIME, THE PT EXSANGUINATED AND DIED. WHILE RESIDENT WAS BEING TRANSFERRED IN LIFT, THE SAFETY STRAP WAS NOT PROPERLY SECURED ALLOWING THE RESIDENT TO FALL FORWARD FROM CHAIR STRIKING HEAD ON FLOOR. THE PT SUFFERED A FRACTURED NECK AND DIED. FEMALE PT IS 85 YRS OLD AND WEIGHS 100 LBS. TH E INVESTIGATION BY THE SERVICE TECH SHOWED THE DEVICE TO BE IN GOOD OPERATIONAL CONTEXT AND DEVICE WAS WITHIN SPECIFICATIONS. THE INVESTIGATION REVEALED THAT THE PT HAD NOT BEEN PROPERLY SECURED BECAUSE THE SAFETY STRAP HAD NOT BEEN PROPERLY USED. THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WOULD NOT FIRE PROPERLY, WHICH RESULTED IN A PUNCTURE TO THE CYSTIC ARTERY. SURGEON REPAIRED THE ARTERY LAPAROSCOPICALLY WITH A 2ND DEVICE. APPROX 1 HR POSTOPERATIVELY, PT WAS RUSH ED BACK TO SURGERY FOR REOPERATION. PT LOST 3 LITERS OF BLOOD AND RECEIVED 7 UNITS OF PACKED RBCS AND 5 VIALS OF HESPAN. THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED THAT THE 2ND FIRING RESULTED IN MALFORMED STAPLES. A 3RD CARTRIDGE WAS INTRODUCED FOR THE 3RD FIRING, WHICH BROKE AND A PIECE FELL INTO THE PT'S ABDOMEN. THE INCISION WAS EXTENDE D TO RETRIEVE THE PIECE FROM THE PT. THE UNIT GOT WET WHEN MEDICS RESPONDED TO THE DROWNING OF AN ELDERLY PT. WHEN MEDICS ATTEMPTED TO TURN THE UNIT ON, THE UNIT WOULD NOT POWER UP. COMPLAINANT ALLEGED THAT THE PT HAD A MASSIVE M.I. WHILE SWIMMING AND EXPIRED. THERE WAS NOT A BACK UP UN IT AVAILABLE. THE COMPLAINANT INDICATED THAT THE ALLEGED MALFUNCTION DID NOT CONTRIBUTE TO THE PT OUTCOME.  l|_9<% 744201960122LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKERPHYSCONTPHYSIO-CONTROL CORP.DEATH9P805460-16CARDIOVASCULARLDDP@.~rqn`WUP<4   744193960119FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONICMEDTRONIC HEART VALVESDEATH99523MMCARDIOVASCULARLWRFO@9ymli[WTO90   744178960119NDM POWER POINT GENERATORNEWDIMEMEDINEW DIMENSIONS IN MEDICINE, INC.SERIOUS INJURYNA35-1000GEN & PLASTIC SURGERYGEIPr@.}ha_Q1&   744169960117PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVEJOHNJOHNPRODJOHNSON & JOHNSON INTERVENTIONAL SYSTEMS CO.DEATHPS1540CARDIOVASCULARMAFF@9||wK?   744168960117PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVEJOHNJOHNPRODJOHNSON & JOHNSON INTERVENTIONAL SYSTEMS CO.DEATHPS1535CARDIOVASCULARMAFF5@9||wK?   744167960119SCHNEIDER WALLSTENT ESOPHAGEAL PROSTHESISSCHNEIDERPERIPHERAL DIV. SCHNEIDER (USA), INC.DEATHE38-2090-95NAGEN & PLASTIC SURGERYESWP5@7vtid?6   744165960117ARJO LIFT HYGIENE CHAIRARJOAARJO MANUFACTURING CO.DEATH210090-01NAGEN HOSPITALFSAF@7k_^[OMD?)$   744131960117AMBULANCE COTFERNWASHFERNO-WASHINGTON, INC.SERIOUS INJURY35A35AGEN HOSPITALFPOP@.h\[XLIF8"   744129960116ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYEZ35WGEN & PLASTIC SURGERYGAGF@.pkk]C7   744128960116LIGACLIP ROTATING MULTIPLE CLIP APPLIERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYAL326GEN & PLASTIC SURGERYGDOP@-mhhZ@4   744127960116LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYER320GEN & PLASTIC SURGERYGDOPx@7ojj\B6   744126960116ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER RELOETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYEVU35GEN & PLASTIC SURGERYGAGF$@7uppbH<   744125960117DEFIBRILLATOR/TEMPORARY NON-INVASIVE PACEMAKERZOLLMEDIZOLL MEDICAL CORP.DEATHPD1400PD1400CARDIOVASCULARLDDFj@7xwtf`ZUC;  LVAL T                                                            THIS PT HAD ANOTHER STENT IMPLANTED IN 11/95. TWO FISTULAUSER FACILITY STATES THAT HARDWARE WAS REMOVED DUE TO POSSIBLE INFECTION. CULTURES WERE NEGATIVE. MALE PT'S DOB IS 8/27/41 AND WEIGHS 130 LBS. IMPLANTED 4/8/94. EXPLANTED 6/28/95. THE PT REPORTEDLY EXPIRED: HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. REPORTED A SECOND DEGREE BURN WHERE PAD HAD BEEN. REPORTED THROUGH CLINICAL STUDY THAT THE PT EXPIRED 16 DAYS POST IMPLANT AFTER EXPERIENCING AN OCCLUSION OF THE MESENTERIC VESSELS 7 DAYS POST IMPLANT THAT RESULTED IN A HEMICOLECTOMY 9 DAYS POST HEMICOLECTOMY. THE PT EXPERIENCED A THROMBOEMBOLSIM AN D EXPIRED. THE PRODUCT WAS NOT EXPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION SITE IN THE PT'S LEFT MAIN CORONARY ARTERY. THE PT EXPIRED DURING THE PROCEDURE. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS EMERGENT PROCEDURE. REPEATED ATTEMPTS WERE MADE TO CONTACT THE COMPL AINANT IN ORDER TO DETERMINE WHETHER THERE WAS ANY POSSIBILITY THAT A CAUSAL RELATIONSHIP MAY HAVE EXISTED BETWEEN THE DEVICE AND THE EVENTS DESCRIBED ABOVE. CO WAS UNABLE TO OBTAIN THE INFO. STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY. AT AN UNKNOWN POINT IN TIME AFTER THE SUCCESSFUL PLACEMENT OF THE STENT, THE PT DEVELOPED THROMBUS DISTAL TO THE STENT SITE AND WAS SENT FOR CORONARY ARTERY BYPASS SURGERY. THE PT EXPIRED DURING THE SURGICAL PROCEDURE. ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT IN ORDER TO DETERMINE WHETHER THERE WAS ANY POSSIBILITY THAT A CAUSAL RELATIONSHIP MAY HAVE EXISTED BETWEEN THE DEVICE AND THE EVENTS DESCRIBED ABOVE. HOWEVER, CO WAS UNABLE TO OBTAIN THE INFO. nLVAL2THE DETHE FRONT CASTER OF A MANUAL WHEELCHAIR BROKE. THE REPORT STATES THE USER FELL, SUSTAINING A BROKEN WRIST, RIGHT FIBULA AND TIBIA. THE WHEELCHAIR INVOLVED IS OVER 8 YRS OLD. ONE OF THE PTS DIED WHILE ON THE VENTILATOR. THE PT'S FAMILY HAS INDICATED A BELIEF THE VENTILATOR CONTRIBUTED TO THE DEATH, WHILE THE COUNTY MEDICAL EXAMINER HAS ATTRIBUTED THE DEATH TO A HEART ATTACK. THE PT WAS A 71 YR OLD MALE QUADRAPLEGIC. THE F AMILY HAS REFUSED TO ALLOW THE RENTAL CO ACCESS TO THE EQUIPMENT BUT HAS INDICATED THAT VENTILATOR WAS NOT ALARMING AND VENTILATING AT THE TIME OF THE DISCOVERY. IT IS NOT KNOWN IF THE VENTILATOR CAUSED OR CONTRIBUTED TO THE EVENT. EMERGENCY PERSONNEL RESPONDED TO A PT DESCRIBED AS IN FULL CARDIAC ARREST. THE PT WAS CONNECTED TO THE DEVICE FOR AUTOMATIC DEFIBRILLATION. BUT ACCORDING TO THE RPTR, THE DEVICE KEPT PROMPTING THE OPERATOR TO "CONNECT ELECTRODES" DESPITE CHANGING THE ELECTRODES AND CABLE. TWO MINS AFTER THE ARRIVAL OF FIRST RESPONDER, PARAMEDICS ARRIVED WITH A MANUAL DEFIBRILLATOR, REMOVED THE DEVICE AND TOOK OVER THE SCENE. THE PT WAS NOT RESUSCITATED AND THE CODE WAS CALLED AT THE SCENE. HOSP PERSONNEL RESPONDED TO A PT DESCRIBED AS IN CARDIAC ARREST. ACCORDING TO THE RPTR, THE OPERATOR WAS NOT ABLE TO GET THE UNIT CLOSE TO THE PT AND THE DEVICE'S COIL CORDS HAD TO BE STRETCHED APPROX 6 FEET. THE REPORT THEN STATED THE DEVICE WOULD N OT TRANSFER ENERGY ON THE 3RD COUNTERSHOCK ATTEMPT. THE PT WAS NOT RESUSCITATED. THE HOSP BIOMED DEPT REPORTED IN AN OBSERVATION OF THEIR EVALUATION THAT THE DEVICE WOULD NOT TRANSFER ENERGY WHEN THE PADDLE COIL CORDS ARE STRETCHED AND THAT AN OPEN C ONNECTION IN THE COIL CORD CONDUCTORS APPEARED TO BE LOCATED NEAR THE DEVICE CONNECTOR END OF THE ASSEMBLY. THE PADDLES ASSEMBLY WAS REPLACED AND THE UNIT RETURNED TO USE. THE ASSEMBLY WAS INADVERTENTLY DISCARDED BY THE FACILITY AND IS NOT AVAIALBLE FOR EVALUATION. ~LVAL{,FD6BSKIN IRRITATION (SOME BLISTERING) REPORTED AS WELTS AROUND WHERE THE ELECTRODE WAS PLACED. TECHNICIAN BELIEVES THAT PT IS HYPERSENSITIVE TO ADHESIVE. THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. UPON INSERTION OF THE TROCAR, THERE WERE NO VISIBLE ABDOMINAL LAYERS. SURGEON REMOVED THE OBTURATOR AND INSERTED THE CAMERA; SURGEON NOTED A MARK ON THE BOWEL AND PROCEEDED WITH THE CASE. AT THE END OF THE PROCEDURE, THE SURGEON NOTED THAT THE TROCAR HAD GONE THROUGH BOTH SIDES OF THE BOWEL. SURGEON CONVERTED TO AN OPEN PROCEDURE, MADE SMALL INCISION, BROUGHT BOWEL LOOP OUT AND TRANSECTED THE BOWEL. THE DEVICE WAS USED DURING A LAPAROSCOPIC TUBAL LIGATION/ENDOMETRIAL ABLATION. THE TROCAR WAS USED AS A CAMERA PORT DURING CASE; ONE SIDE OF THE LIGATION WAS COMPLETE AND WHILE DOING THE OTHER SIDE, PNEUMO WAS LOST. WHEN PNEUMO WAS REESTABLISHED, A B URN WAS OBSERVED IN THE SEROSA OF THE BOWEL. A GENERAL SURGEON WAS CONSULTED AND PT WAS ADMITTED TO THE HOSP FOR OBSERVATION. INFO RECEIVED FROM THE CONTACT INDICATED THAT AN INSULATION SLEEVE FROM A PHACOEMULSIFICATION NEEDLE WAS INAPPROPRIATELY PLACED ON ANOTHER UNKNOWN PHACO NEEDLE AND USED DURING A CATARACT EXTRACTION PROCEDURE. THE LIMITED INFO RECEIVED TO DATE INDICAT ES THE PT SUFFERED AN OPAQUE CORNEA. CO WAS INFORMED BY 1 OF CO'S FIELD SVC REPS OF 2 DEATHS BEING REPORTED THROUGH THE MEDIA ALLEGING A CONNECTION BETWEEN THE DEATHS AND A GAS STERILIZER, POSSIBLY ONE PRODUCED BY CO. STERILIZER WAS EVALUATED BY THE HOSP AND AN OUTSIDE PARTY. REPORTS FR OM THE HOSP RISK MGMT COORDINATOR INDICATED THAT THE STERILIZER IS OPERATING PROPERLY. THE STERILIZER HAS NOT BEEN EVALUATED BY CO OR CO TECH PERSONNEL. THE CDC HAS DETERMINED THAT THE DEATHS ARE A RESULT OF ENDOTOXINS WHOSE SOURCE HAS NOT YET BEEN D ETERMINED. NO FURTHER ACTION WILL BE TAKEN BY CO UNLESS WARRANTED BY ADD'L INFO. DEVICE MFR DATE 1985. LVAL_9<BW 744124960117INTRA-AORTIC BALLOON CATHETETHE FRONT CASTER OF A MANUAL WHEELCHAIR BROKE. THE REPORT STATES THE USER FELL, SUSTAINING A BROKEN WRISSKIN IRRITATION REPORTED AS WELTS AROUND WHERE THE ELECTRODE WAS PLACED. NO FOLLOW-UP TREATMENT REQUIRED. TECHNICIAN BELIEVES THAT PT IS HYPERSENSITIVE TO ADHESIVE. A PT WITH RESPIRATORY PROBLEMS WENT INTO ARREST ONE WEEK PRIOR TO DYING. AT THE TIME OF ARREST, THE HOSP INTUBATED THE PT. THE TUBE IN FOR APPROX 6-7 DAYS. AFTER APPROX 3 DAYS, THE CUFF HAD DEFLATED. THE PT WAS NOT REINTUBATED. THE TUBE WAS THEN REMO VED AND DISCARDED. PT WAS AT PREGNANCY GESTATIONAL AGE OF 21 +2 WEEKS WHEN SHE COMPLAINED OF VAGINAL BLEEDING. HER DR RECOMMENDED SHE TAKE TYLENOL AND REST, SINCE SHE REQUESTED TO REST AT HOME AND NOT GO TO THE HOSP. SHE AGREED TO GO TO THE ER IF ANY BLEEDING WOULD OCC UR. THE PT WAS ADMITTED TO THE HOSP ON 12/9/95 AFTER COMPLAINING OF BLEEDING AND DELIVERED THE BABY THAT NIGHT WHICH DID NOT SURVIVE. DEVICE TESTING UPON RECEIPT AT THE MFG FACILITY INDICATED THE SENSOR WAS WITHIN THE OPERATING SPECS FOR THE RECERTIF ICATION TEST. DR PERFORMED CATARACT SURGERY ON THE LEFT EYE, WHICH WAS COMPLICATED BY UNLIMITED CHOROIDAL HEMORRHAGE. ACCORDING TO DR THIS CAUSED A DIFFICULT INTRAOCULAR LENS INSERTION AND THEREFORE, EXTENDED THE OPERATION TIME. THE PROLONGED OPERATION TIME CAUSED THE PT TO BE EXPOSED TO THE LIGHT OF THE MICROSCOPE FOR A LONGER TIME PERIOD THAN NORMAL, WHICH ALLEGEDLY RESULTED IN RETINAL BURN. PT'S CORRECTBLE VISION ACUITY IS 20/70-80.FEMALE PTS AGE IS 80. EQUIPMENT WAS EVALUATED BY ONE OF CO'S TECHNICIANS AN D ALL WAS FOUND TO BE WITHIN SPECIFICATIONS, EXCEPT FOR THE RETINAL PROTECTION DEVICE WHICH WAS BROKEN AND FILTER WAS IN PLACE FOR THE YELLOW LIGHT. RECOMMENDED A FILTER BE INSTLLED AND MADE REMEDIAL REPAIR TO PRD, WILL COMPLETE REPAIR NEXT WEEK. DO CTOR IS WELL AWARE OF THE RELATIONSHIP BETWEEN RETINAL BURNS AND EXPOSURE TO LIGHT OVER TIME. QLVALjd^e\2Q853803MED DEVICE960130INTERMEDIATE HI-LO TRACHEAL TUBEMALLMEDIMASTENT WAS INAPPROPRIATELY PLACED AT THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY WHICH RESULTED IN DISSECTION OF THE VESSEL. THEREFORE, THE PHYSICIAN ATTEMPTED TO PLACE A 2ND STENT AT THE DISSECTION SITE. DURING THE PLACEMENT OF THE 2ND STENT, THE PT EXPERIENCED CARDIAC ARREST AND SUBSEQUENTLY EXPIRED. OPERATOR ACTIVATED TABLE TO POSITION PT. TABLE DROVE TO BOTTOM LINING AND STOPPED; REASON UNKNOWN. PT'S BLADDER WAS REPORTED TO BE PERFORATED. PT'S HOSPITALIZATION HAS BEEN EXTENDED; NO SURGICAL INTERVENTION WAS REQUIRED. HOSP'S RISK MGMT DEPT REPORT S PT IS DOING OK. TABLE WAS SERVICED BY CO SVC REP ON JANUARY 17 AND IS FUNCTIONING PROPERLY. NO CAUSE OF THIS EVENT COULD BE IDENTIFIED. HOSP IS CONTINUING TO USE THE TABLE. THE PT REPORTEDLY EXPIRED: HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C0 33-10. THE PT REPORTEDLY EXPIRED: HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C0 34-10. EMT ARRIVED ON SCENE OF A PERSON DESCRIBED IN CARDIAC ARREST. A B.L.S. TEAM WAS ALREADY ON SCENE AT THE TIME OF ARRIVAL. THE B.L.S. TEAM HAD USED THEIR AED TO ANALYZE THE PT RHYTHM. THEIR AED TWICE RENDERED A NO SHOCK INDICATED DECISION. THIS DEVICE WAS REMOVED AND THE EMTS CONNECTED THEIR SEMI-AUTOMATIC DEFIBRILLATOR TO THE PT. THE SEMI-AUTOMATIC DEFIBRILLATOR ANALYZED THE PT RHYTHM AND TWICE RENDERED A NO SHOCK INDICATED DECISION. THE DEVICE THEN REPORTEDLY DISPLAYED "MEMORY MODULE" AND SVC M ANDATORY". USE OF THE DEVICE WAS TERMINATED AND PT CARE CONTINUED BY PARAMEDICS WITH A MANUAL DEFIBRILLATOR. THE PT WAS PRONOUNCED ON SCENE BY MED CONTROL. pLVAL&O8 REPORTED THAT THE UNIT "BLEW OUT FROM THE WALL". INSPECTION OF THERETURNED UNIT INDICATED EVIDENCETHE AED UNIT DID NOT DETECT THAT THE PT WAS IN V-FIB THEREFORE DID NOT DEFIBRILLATE THE PT DURING THE TRANSPORT TO THE HOSP. THE PT SUBSEQUENTLY EXPIRED. THE 2ND TIME THE MEDICS ATTEMPTED TO DEFIBRILLATE THE PT, STATUS 90 APPEARED ON THE SCREEN. MEDICS CHARGED THE UNIT AGAIN AND WERE ABLE TO DEFIBRILLATE THE PT SEVERAL TIMES. THE PT DID NOT SURVIVE THE CODE. A FEMALE CONSUMER WEARING A PAIR OF SUNGLASSES WHILE PLAYING SOFTBALL, WAS STRUCK IN THE FACE BY A THROWN BALL. THE IMPACT BROKE THE NOSE OF THE CONSUMER AS WELL AS THE LEFT LENS OF THE SUNGLASSES. A CUT TO THE NOSE RESULTED FROM THE BROKEN LENS. THE CONSUMER WAS TAKEN TO THE HOSP FOR MEDICAL TREATMENT. THE BROKEN NOSE WAS SET AND THE CONSUMER HAS SINCE FULLY RECOVERED. MFR DATE: 1988-1989 MODEL. CO'S SUNGLASS LENSES ARE CHEMTEMPERED AND 100% FDA DROPBALL TESTED PRIOR TO BEING SOLD. THE PT REPORTEDLY EXPIRED; HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. THE PT REPORTEDLY EXPIRED DUE TO STROKE, HYPOXEMIA AND CARDIAC ARREST. PENCIL WAS LAID ON SURGICAL FIELD WITHOUT THE HOLSTER THAT WAS PROVIDED WITH THE PENCIL. RISK MGR REPORTED THAT THE PENCIL ACTIVATED WHEN IT WAS PLUGGED IN RESULTING IN PT BURN. DURING AN INCIDENT CALL INVOLVING A 70-YR-OLD FEMALE PT IN CARDIAC ARREST, THE CUSTOMER REPORTEDLY COULD NOT REMOVE THE PROTECTIVE PLASTIC LINER FROM TWO PAIR OF ELECTRODE PADS TO APPLY THE PADS TO THE PT. THE CUSTOMER THEN LAID THE 2ND PAIR OF PADS MINUS THE ADHESIVE RING ON THE PT. THE DEFIBRILLATOR DELIVERED A SHOCK TO THE PT, GAVE A "NO SHOCK INDICATED" PROMPT, DELIVERED A 2ND SHOCK TO THE PT, THEN GAVE ANOTHER "NO SHOCK INDICATED" PROMPT. CPR WAS ADMINISTERED TO THE PT BETWEEN SHOCKS AND DU RING TRANSPORT TO A HOSP. THE PT EXPIRED 12 HRS AFTER BEING ADMITTED TO INTENSIVE CARE. LVALB& hIxEETAL CAME FROM THIS INSTRUMENT AN856874MED DEVICE960103LIFEPAK MONITORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION59-00283-14CARDIOVASCULARLDDF@pvvjifXNMB.&856873MED DEVICE960103AUXILIARY POWER SUPPLY FOR THE LIFEPAKPT DEATH. LOCAL DISTRICT ATTY AND MEDICAL EXAMINER OFFICE REQUESTED THAT CO CEASE ITS INVESTIGATION UNTIL LOCAL LAW ENFORCEMENT COMPLETED ITS INVESTIGATION. PARAMEDICS RESPONDED TO CARDIAC ARREST PT ON ROOFTOP DURING SNOWFALL. PT WAS SHOCKED 3 TIMES ENROUTE TO HOSP. ON THE FOURTH SHOCK DEVICE DISPLAYED "FAULT" CONDITION. PT EXPIRED. INVESTIGATION OF DEVICE BY MFR FOUND MOISTURE DAMAGE. LABELING WARNS USE R OF EQUIPMENT FAILURE HAZARD WHEN USE CONDITIONS WHERE PROLONGED EXPOSURE TO OR EXCESSIVE CONTACT WITH MOISTURE CAN OCCUR. AN OTHERWISE HEALTHY 22-YR-OLD MALE UNDERWENT A RIGHT SHOULDER ARTHROSCOPY. THERE WERE NO APPARENT PROCEDURE RELATED PROBLEMS REPORTED. THE PT WAS EXTUBATED IN THE USUAL FASHION WITHOUT PROBLEMS. THIRTY MINS POST-OP PT BEGAN TO EXPERIENCE DEPRESSED R ESPIRATION AND UNRESPONSIVENESS. NARCAN WAS ADMINISTERED. PT CONTINUED TO DETERIORATE, DEVELOPED ACUTE RESPIRATORY DISTRESS, WAS "CODED" BUT DIED IN SPITE OF ALL RESUSCITATIVE EFFORTS. PRELIMINARY ME AUTOPSY RESULTS SUGGEST "MASSIVE PULMONARY EDEMA." ETIOLOGY CURRENTLY UNDETERMINED. A 64-YR-OLD FEMALE PT DIED WHILE ON THE VENTILATOR. WHEN THE PT WAS PLACED ON THE VENTILATOR THE BREATH RATE WAS SET AT 12 BPM. LATER THE PT'S HEART RATE DECREASED AND THE VENTILATOR BREATH RATE WAS FOUND SET AT 42 BPM. INVESTIGATION FOUND THE MEDWAT CH REPORT WAS FILED DUE TO THE DEATH AND BECAUSE THE CAUSE FOR THE VENTILATOR BREATH RATE SETTING CHANGE WAS UNKNOWN. SINCE THE REPORT WAS FILED, THE CUSTOMER INSPECTED AND TESTED THE VENTILATOR, AND FOUND IT FUNCTIONED TO MFR'S SPECS. THE CUSTOMER'S INVESTIGATION FOUND THE VENTILATOR DID NOT MALFUNCTION AND DID NOT DIRECTLY CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THE CUSTOMER DECLINED AN INSPECTION BY THE MFR AND PLACED THE UNIT BACK IN SVC. 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BAXTER HEALTHCARE CORP.DEATH2625NACARDIOVASCULARLWRP@Myxugea\4-   744954960129PATIENT LIFTINVACAREINVACARE CORP.DEATH9801NAGEN HOSPITALFSAP@MVJIF:84/!   744908960126KAZ VAPORIZERKAZKAZ MANUFACTURINGSERIOUS INJURY285ANESTHESIOLOGYKFZP @M]QPM??<.   7448819601268F, 110CM OPTICATH W/HEPARINABBOLABOABBOTT LABORATORIESDEATHNA503280401CARDIOVASCULARDYGP@MrfebTKID1)   744880960126RX PIGGYBACK WITH LAV VALVESABBOLABOABBOTT LABORATORIESDEATHNA190030448GEN HOSPITALFPAP@Lpdc`TKID1)  Ja+np711249MED DEVICE950519EDWARDS-DUROMEDICS BILEAFLET THE PLUG HAD SEPA 745178960126HIGH FLOW FOUR WAY STOPCOCKMEDEXMEDEX, INC.SERIOUS INJURYNAMX934-11GEN HOSPITALFMGP@Ql`_\PHF8-(   745177960130FRESENIUS HEMODIALYSIS SYSTEMFRESENIUSFRESENIUS USA, INC.DEATH2008DNAGASTRO & UROLOGYFIIP@PrfebRPKF3*   745167960129HARMONIC SCALPEL LAPAROSONIC COAGULATING SETHIENDOSURGETHICON ENDO-SURGERY, INC.DEATHLSC15GASTRO & UROLOGYKNSP@P{zwgbb]C7   745166960129ENDOPATH BABCOCK GRASPERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNABB10GEN & PLASTIC SURGERYGCJP@Pxwt_[YK1%   745165960129PROXIMATE R L PLUS LINEAR STAPLERETHIENDOSURGETHICON ENDO-SURGERY, INC.DEATHTP60GEN & PLASTIC SURGERYGAGPm@Pvur]YYT:.   745163960129LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNAER320GEN & PLASTIC SURGERYGDOP@Oqlj\B6   745104960130LIFEPAK AUTOMATIC ADVISORY DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.DEATH250805160-00CARDIOVASCULARMKJP[@PtspbYVQ=5   745089960129ARGYLE UMBILICAL VESSEL CATHETERSHERMEDISHERWOOD MEDICAL CO.SERIOUS INJURYNA888-160218GEN HOSPITALFOSP|@PsrocYWI5-   745085960129PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVEJOHNJOHNPRODJOHNSON & JOHNSON INTERVENTIONAL SYSTEMS, CO.DEATHPS1530CARDIOVASCULARMAFF@O}}xK?   745076960129SURGICAL SIMPLEX P BONE CEMENTHOWMEDICAHOWMEDICA, INC.DEATH6191-1-001ORTHOPEDICLODF@Ol`_\RHHC4+   745075960129SURGICAL SIMPLEX P BONE CEMENTHOWMEDICAHOWMEDICA, INC.DEATH6191-1-001ORTHOPEDICLODF@Ol`_\RHHC4+   745039960126HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHELECTRODE PAD902400CARDIOVASCULARLDDF@Oj^]ZLF94   745038960126HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.DEATHHS 1000S900028CARDIOVASCULARMKJF@OeYXUGA94   744995960129AMBULANCE COTFERNWASHFERNO-WASHINGTON, INC.SERIOUS INJURY29M29MGEN HOSPITALFPOP@Oh\[XLIF8"  a}|c?7P]P] 853310960125STORZ MVS ANTERIOR VITRECTOMY PACKSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNAMVS3201OPHTHALMICMLZF@Symli_XVK7/   853306960125STORZ DAVIS MOUTH GAGSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNAN7451EAR NOSE THROATKBNF@Rocb_PKI>*"   853304960125STORZ BASIC IRRIGATION/ASPIRATION PACKSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP4101OPHTHALMICKYGF@R|polb\ZO;3   853301960125STORZ PREMIERE STAINLESS STEEL PHACOEMULSIFICATIONSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP8020NIOPHTHALMICHQCF@R|{xnlf[G?   853298960125STORZ MVS ANTERIOR VITRECTOMY PACKSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNAMVS3201OPHTHALMICMLZF@Qymli_XVK7/   853297960125STORZ MICROSEAL STAINLESS STEEL PHACOEMULSIFICATIOSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP8040NAOPHTHALMICHQCF@Q|{xnlf[G?   853287960130SOFT-VU OMNI FLUSH CATHETERANGIODYNAMICSANGIODYNAMICS DIV. E-Z-EM, INC.MALFUNCTIONNA10732301CARDIOVASCULARDQOF@@S{zwia_T5(   748453960226TAMPAX TAMPONTAMBRANDSTAMBRANDS, INC.DEATHNANAOB/GYNHEBPu@QQEDA;972#   745719960126MONOJECTOR SYRINGE HARDPACKSHERMEDISHERWOOD MEDICAL CO.SERIOUS INJURYNAGEN HOSPITALFMFPw@Rpdc`TTRD0(   745622960109CONTOUR SYSTEMBENNXRAYBENNETT X-RAY TECHNOLOGIESSERIOUS INJURYM-1500 GM-CTRRADIOLOGYIZHP@RqedaXSK=#   745240960130FLEXIFLO COMPANION ENTERAL NUTRITION PUMPROSSPRODROSS PRODUCTS DIV. ABBOTT LABORATORIESSERIOUS INJURY84NAGEN HOSPITALLZHF@Qvtrd>6   745230960130PROXIMATE I L S INTRALUMINIAL STAPLERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNACDH33GEN & PLASTIC SURGERYGAGPW@QmhfX>2   745229960130PROXIMATE HEAVY WIRE LINEAR STAPLERETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNATLH30GEN & PLASTIC SURGERYGAGP@QkfdV<0   745228960130ENDOPATH DISPOSABLE SURGICAL TROCARETHIENDOSURGETHICON ENDO-SURGERY, INC.SERIOUS INJURYNA512SGEN & PLASTIC SURGERYGCJP@QjfdV<0  WwV1'1$ }|vpjd^XRLF@:4.("  856544960105STORZ JANSEN-MIDDLETON SEPTUM FORCEPSSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNAN3076EAR NOSE THROATKAEF @Xsro`[YN:2   856543960105STORZ PREMIERE BIPOLAR CORDSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP9400OPHTHALMICHQOF@TqedaWQOD0(   856542960105STORZ PREMIERE STAINLESS STEEL PHACOEMULSIFICATIONSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNA11547OPHTHALMICHQCF@T{zwmhf[G?   856533960109FOCUS RTP RELEASE 1.1.2COMPMEDISYSTCOMPUTERIZED MEDICAL SYSTEMS, INC.MALFUNCTION9200NARADIOLOGYIYEFqV|polca]R0$   856456960102HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.MALFUNCTIONELECTRODE PADS902400CARDIOVASCULARMKJF@UqedaSM?4   856046960105HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.MALFUNCTIONHS 2000900050CARDIOVASCULARMKJF@Uj^]ZLF?4   856045960105HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.MALFUNCTIONHS 3000QR920054CARDIOVASCULARMKJFN@Ul`_\NH?4   854765960104AQUA K-PUMPGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONK-2064N0200PHYS MEDILOF@TeYXUMFB7    853803960130INTERMEDIATE HI-LO TRACHEAL TUBEMALLMEDIMALLINCKRODT ANESTHESIOLOGY DIV.MALFUNCTIONNA86450ANESTHESIOLOGYBTRF@Tyxugb`U5-   853772960125STORZ PREMIERE STAINLESS STEEL PHACOEMULSIFICATIONSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP8020NAOPHTHALMICHQCFJ@T|{xnlf[G?   853483960125STORZ PREMIERE MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP1602 400NAOPHTHALMICHQEF@T}qpmcaWL80   853475960125STORZ PREMIERE STAINLESS STEEL PHACOEMULSIFICATIONSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP8020NAOPHTHALMICHQCF@T|{xnlf[G?   853392960125STORZ PREMIERE MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP1602NAOPHTHALMICHQEF@Symli_]WL80   853378960125STORZ PREMIERE MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP3472NAOPHTHALMICHQEF @Symli_]WL80  LVAL_ HgGTMENT PLAN "ENTER BEAM #1 AND ENTER857004MED DEVICE960103HI FLO TWO GANG FOUR WAY STOPCOCKMEDEXMEDEX, INC.MALFUNCTIONNAMX934-2LGEN HOSPITALFMGFG@ryymli]USH=8856921MED DEVICE960108STORZ PREMIERE MICROSURGICAL SYSTEMTHE PT UNDERWENT REOPERATION FOR THE REPLACEMENT OF THE PROSTHESIS REPORTEDLY DUE TO INSUFFICIENCY, STENOSIS AND RESIDUAL ATRIAL SEPTAL DEFECT. A PT RECEIVED A HEMOTHORAX DURING A CATHETER PLACEMENT PROCEDURE. REQUIRING BLOOD AND CHEST TUBE PLACEMENT. THE FACILITY NOTED IN THE REPORT THAT THE GUIDE WIRE WAS FOUND TO BE "UNWOUND" UPON REMOVAL. IN FOLLOW-UP WITH THE FACILITY, IT WAS LEARNED TH AT IT WAS ACTUALLY A PNEUMOTHORAX FOUND BY X-RAY. ACCORDING TO THE FACILITY, THE LEFT SUBCLAVIAN INSERTION WAS "VERY DIFFICULT" DUE TO THE PT'S LARGE SIZE. THE MFR'S ANALYSIS IS THAT THE GUIDEWIRE WAS NOT LIKELY THE CAUSE OF THE PNEUMOTHORAX. BUT BEC AME UNWOUND AS A SECONDARY EFFECT OF THE DIFFICULT PROCEDURE. PNEUMOTHORAX IS LISTED IN THE INSTRUCTIONS AS A POTENTIAL COMPLICATION OF A SUBCLAVIAN INSERTION AND IS A NORMAL RISK OF THE PROCEDURE. THE PT IS REPORTED AS FULLY RECOVERED FROM THE EVENT . THE OPERATIVE PROCEDURE WAS PLANNED PHACOEMULSIFICATION OF CATARACT WITH IOL IMPLANTATION. THE DR NOTED THAT HE NORMALLY IMPLANTS THIS LENS WITH NO PROBLEMS, HOWEVER, WHILE IMPLANTING THIS PARTICULAR LENS, HE NOTICED THAT ONE OF THE HAPTICS SEEMED TO "GRAB" THE POSTERIOR CAPSULE, AND PERFORATED THE BAG. THIS LENS WAS REMOVED, AND A SULCUS FIXATION IMPLANT WAS ACCOMPLISHED. AN ANTERIOR VITRECTOMY WAS ALSO PERFORMED. AT THE TIME OF THIS REPORT, THE PT IS DOING WELL VISUAL ACUITY IS 20/20. THE DR H AS REQUESTED THAT CO EXAMINE AND CHECK THE TECH SPECIFICATIONS FOR THIS LENS, WHICH IS BEING RETURNED FOR TECH ANALYSIS. THE RESULTS OF MFR BATCH CHECK ANALYSIS AND SUBJECT LENS EXAM ARE NOT YET AVAILABLE. PT DEATH. LOCAL DISTRICT ATTY AND MEDICAL EXAMINER OFFICE REQUESTED THAT CO CEASE ITS INVESTIGATION UNTIL LOCAL LAW ENFORCEMENT COMPLETED ITS INVESTIGATION. LVALn<{I.857171MED DEVICE960112SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM780GEN HOSPITALFNMFy@srrfebVPI>'857170MED DEVICE960111KANTHE DEVICE WAS IN USE ON A PT IN ACUTE MI, CODE SITUATION. TOTAL TIME FOR THE RESUSCITATION ATTEMPT WAS APPROXIMATELY 2 HRS. ABOUT HALFWAY THROUGHT THE RESUSCITATION ATTEMPT, OXYGEN FLOW WAS SET TO "FLUSH" (IN EXCESS OF 20 LPM) IN AN EFFORT TO RAISE THE PT'S 02 SATURATION LEVELS. (WHEN THE OXYGEN FLOW WAS INCREASED THE OXYGEN RESERVOIR ON THE DEVICE WAS OBSERVED TO GO FLAT. THE R/T VISUALLY INSPECTED THE BAG, NOTED A "TEAR", QUICKLY REPAIRED THE AREA WITH TAPE, AND CONTINUED THE RESUSCITATION FO R APPROXIMATELY 15 TO 20 MINUTES LONGER. PT EXPERIENCED MORE MI EVENTS DURING THE RESUSCITATION ATTEMPT, AND DID NOT SURVIVE. THE FACILITY DOES NOT BELIEVE THE DEVICE CONTRIBUTED TO THE PT OUTCOME. RPTR STATED THAT THE PT DIED, BUT WOULD NOT PROVIDE ANY INFO REGARDING THE PT, THE EVENT, EVENT DATE, OR THE CO PRODUCT INVOLVED. THIS REPORT IS BEING FILED ASSUMING CO DEVICE WAS INVOLVED. THE NUMBER OR PTS INVOLVED IS ASSUMED TO BE 1, BUT THIS HAS NOT BEEN CONFIRMED BY THE RPTR. THE PT WENT INTO CARDIAC ARREST ON 1/11/96. THE DR USED THE TRACHEAL TUBE FOR NASAL INTUBATION. THE CUFF WAS CHECKED PRIOR TO INTUBATION. THE 7.0 MM (CODE 5-10114) TUBE PASSED BY INTO THE TRACHEA. MAGILL FORCEPS WERE NOT USED. THE TUBE WAS BLINDLY PA SSED INTO THE TRACHEA AND BREATH SOUNDS CONFIRMED. THE CUFF WAS THEN INFLATED, A LARGE LEAK WAS NOTED IN THE CUFF. THE TUBE WAS THEN WITHDRAWN. BLEEDING NOTED. THE PT WAS THEN REINTUBATED WITH A 7.5 MM TUBE (CODE-10115). THIS TIME SOME NASAL FORCEPS WERE USED WITH CARE TO NEVER TOUCH THE CUFF. AGAIN THE CUFF WAS CHECKED PRIOR TO PASSING THE TUBE. THE DR TRIED TO INFLATE THE CUFF AND A LARGE LEAK WAS NOTED. THE SECOND TUBE WAS REMOVED AND THE PT WAS ORALLY INTUBATED WITH A 8.0 MM TUBE. NO LEAK IN THE CUFF WAS NOTED. BOTH TRACHEAL TUBES HAVE BEEN RETURNED TO THE MFG FACILITY FOR INVESTIGATION. LVALNBN$M857367MED DEVICE960112STORZ PROTEGE ANTERIOR SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADPX100OPHTHALMICHQEF@x}}qpmc][P<4857366MED DEVICE960112STAINLESS STEEL MTHE PT REPORTEDLY EXPIRED DUE TO ENDOCARDITIS AND STROKE. SKIN IRRITATION REPORTED AROUND THE ELECTRODE PLACEMENT SITE. NO FOLLOW-UP TREATMENT REQUIRED. SKIN DISCOLORATION REPORTED WHERE ELECTRODES HAD BEEN. A SEPTIC PT UNDERWENT RE-OPERATION AFTER DEVELOPING A STAPH INFECTION IN AN ALLOGRAFT RECEIVED EARLIER. FOUR AND 1/2-HRS AFTER THE INITIATION OF CARDIOPULMONARY BYPASS THE USER NOTICED THAT THE VENOUS AND ARTERIAL BLOOD WERE VERY DARK. THE OXYGENATOR WAS REMOVED AND REPLACED WITHOUT INCIDENT, RESULTING IN RECOVERY OF EXPECTED BLOOD OXYGEN LEVELS. SOMETIME AFTER THE CONCLUSION OF SURGERY THE PT EXPIRED. THE HOSP PERFUSIONIST RESPONSIBLE FOR QUALITY ASSURANCE COMMENTED THAT THE OXYGENATOR WAS NOT RESPONSIBLE FOR THE PT'S DEATH. THERE IS NO INFO AVAILABLE AT THIS TIME FROM THE PERFUSIONIST WHO WAS IN ATTENDANCE. IN PACING A PT THE UNIT ALLEGEDLY FAILED. THE CUSTOMER USER ALLEGED THAT THE FAILURE "POSSIBLY CONTRIBUTED" TO THE PT DEATH. UPON INVESTIGATION AT CO THE DEFIBRILLATOR WAS FOUND TO HAVE 2 BROKEN INTERNAL SUPPORT POSTS, AND THE RIGHT LEG ECG LEAD WAS DAMAGED NEAR THE CONNECTOR (PT END) AND WAS COVERED WITH INSULATING TAPE. UPON TESTING, THE CABLE WAS SUSPECT AND HAD AN INTERMITTENT CONNECTION. EMTS RESPONDED TO A PERSON WITH A HISTORY OF HEART DISEASE, DESCRIBED AS IN CARDIAC ARREST AND DIAGNOSED AS IN VENTRICULAR FIBRILLATION. ACCORDING TO THE RPTR, THE DEVICE WAS CHARGED 3 TIMES AT THE SCENE, BUT WOULD NOT TRANSFER ENERGY TO THE PT. THE PT WAS LOADED INTO THE AMBULANCE FOR TRANSPORT TO THE HOSP. THE RPTR STATED THAT, DURING TRANSPORT, THE DEVICE OPERATED PROPERLY, TRANSFERING ENERGY TO THE PT FOR 5 SUBSEQUENT COUNTERSHOCKS. THE RPTR STATED THE PT ARRIVED AT THE HOSP WITH AN EMD RHYT HM AND WAS MOST LIKELY NOT RESUSCITATED. LVALuN@<% 744201960122LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKERPHYSCONTPHYSIO-CONTROL CORP.DEATH9P805460-16CARDIOVASCULARLDDP@~rqn`WUP<4   744193960119FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRSKIN DURING AN INCIDENT CALL INVOLVING A 66 Y/O MALE PT WITH A HISTORY OF ASTHMA, CARDIAC, AND HYPOTENSION WHO WAS IN CARDIAC ARREST, AN ELECTRODE PAD WOULD NOT SNAP ONTO THE WHITE PT CABLE LEAD. THE OPERATORS OPENED A SECOND SET OF PADS AND SNAPPED ANOTH ER PAD PROPERLY INTO PLACE ONTO THE WHITE PT CABLE LEAD. FOUR DEVICE ASSESSMENTS WERE THEN PERFORMED WHICH RESULTED IN "NO SHOCK INDICATED" PROMPTS. AN ALS TEAM THEN ARRIVED AND ASSUMED PT CARE. THE PT WAS TRANSPORTED TO A HOSP EMERGENCY ROOM WHERE H E WAS PRONOUNCED. DURING AN INCIDENT CALL INVOLVING A 67 Y/O FEMALE PT WITH A HISTORY OF ASTHMA WHO WAS IN CARDIAC ARREST, THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECKED AND REPOSITIONED THE PADS, CHANGED THE BATTERY, THEN CHANGED TH E PADS, BUT THE PROMPTS WOULD NOT CLEAR. AN ALS TEAM THEN ARRIVED AND ASSUMED PT CARE USING A DEFIBRILLATOR. THE PT'S RHYTHM WAS DETERMINED TO BE JUNCTIONAL EMD AND NONSHOCKABLE WHICH CHANGED TO ASYSTOLE. THE OPERATORS STATED THAT AT NO TIME DID THE PT HAVE A SHOCKABLE RHYTHM. THE PT WAS TRANSPORTED TO A HOSP EMERGENCY ROOM WHERE SHE WAS PRONOUNCED. DURING TESTING BY THE CUSTOMER AFTER THE INCIDENT, THE DEVICE REPORTEDLY AGAIN DISPLAYED "CHECK ELECTRODES" PROMPTS. DURING AN INCIDENT CALL INVOLVING AN 84 Y/O MALE PT IN CARDIAC ARREST, THE FIRE DEPT PERSONNEL HAD ADMINISTERED CPR FOR APPROX 5 MINUTES PRIOR TO THE APPLICATION OF THE DEVICE. THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS AND A VENTRICU LAR TACHYCARDIA RHYTHM AT A RATE OF 300 BPM. THE OPERATORS CHECKED THE PADS AND CABLES, CHANGED THE BATTERY, AND POWERED THE DEVICE OFF AND ON AGAIN. THE DEVICE THEN REPORTEDLY DISPLAYED "CHECK MODULE" PROMPTS. CPR WAS ADMINISTERED UNTIL AN ALS TEAM ARRIVED AND ASSUMED PT CARE. THE PT WAS NOT RESUSCITATED. FLVALXeN@]}"A NEW TUBING WAS USED TO ESTABLISH A LEFT EXTERNAL JUGULAR IV SITE. WHILE PUSHING AN IV MEDICATION, THE TUBING CAME APART AT THE DISTAL LATEX SLEEVE AREA. HOSP WAS UNABLE TO RECONNECT THE TUBING. IT WAS REPLACED WITH A NEW SET. THAT TUBING ALSO BLEW APART AT THE SAME LOCATION. HOSP WAS ABLE TO RECONNECT THIS TUBING ONLY TO HAVE IT COME LOOSE WHILE PUSHING DRUGS AGAIN. THE SET WAS THEN REPLACED WITH A DIFFERENT TYPE OF TUBING." THE PT WAS IN FULL ARREST AND RESUSCITATIVE EFFORTS WERE NOT SUCCESS FUL. THE ACCOUNT CONTACTS REPORT THE OUTCOME OF THE EVENT WAS NOT CERTAIN, BUT THE SET COMING APART DID NOT HELP THE SITUATION." NO ADD'L INFO IS AVAILABLE AT THIS TIME. "THE LATEX SLEEVE FELL OFF THE SET DURING A CODE SITUATION. THIS OCCURRED WHILE IN USE IN AN AMBULANCE IN ROUTE TO THE HOSP. A SECOND SET WAS THEN PRIMED AND USED TO ADMINISTER 23 DIFFERENT IV PUSH MEDICATIONS. THEN, AFTER ARRIVING AT THE HOSP, THE L ATEX SLEEVE ON THE NEW SET "BLEW OFF" WHEN ADMINISTERING A PUSH MEDICATION THROUGH THE LUER ACTIVIATED VALVE." THE RESUSCITATIVE EFFORTS WERE NOT SUCCESSFUL AND THE PT EXPIRED. THE PT AGE AND DIAGNOSIS WERE NOT AVAILABLE. HOSP CONTACTS REPORTED "THE PT WAS IN FULL ARREST AND THE OUTCOME UNCERTAIN DURING THE EVENT, HOWEVER, THE SET COMING APART DID NOT HELP THE SITUATION." NO ADD'L INFO IS AVAILABLE AT THIS TIME. A TWO LITER BAG OF TPN WAS TO BE DELIVERED AT 100 ML/HR OVER 20 HRS. TEN HRS LATER, THE BAG WAS FOUND EMPTY. THE PT WAS MOVED TO A HOSP FOR EVAL. THE PT RECEIVED IV FLUIDS TO OFF SET THE OVERINFUSION AND WAS PUT ON 5L OF OXYGEN BECAUSE HE HAD FLUID I N HIS LUNGS. THE PT HAS RECOVERED FROM THE INCIDENT. THE INFUSION PUMP IS BEING RETURNED TO CO FOR EVAL. DURING A PHACOEMULSIFICATION PROCEDURE, THE ASPIRATION FUNCTION OF THIS OPHTHALMIC MICROSURGICAL SYSTEM FAILED. AS A RESULT THE PT SUFFERED A BROKEN CAPSULE AND THE PHYSICIAN PERFORMED AN ANTERIOR VITRECTOMY PROCEDURE. THERE WAS NO ADD'L PT INJURY. LVALg\ @ @THIS PT HAD ANOTHER STENT IMPLANTED IN 11/95. TWO FISTULAS DEVTHE PTHE PT REPORTEDLY EXPIRED; THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. THE LEGS OF A PT LIFT WERE NOT LOCKED DURING TRANSFER. THIS RESULTED IN THE LIFT BECOMING UNSTABLE AND THE PT FALLING TO THE FLOOR. THE PT DEVELOPED A SUBDURAL HERMATOMA AND DIED ONE WEEK AFTER THE INCIDENT. CAUSE OF DEATH HAS NOT BEEN DETERMINED. TH E HEALTH CARE PROFESSIONAL SUBMITTING THE REPORT STATED THE INCIDENT WAS CAUSED BY IMPROPER TRANSFER TECHNIQUE AND NOT A DEVICE MALFUNCTION. A 8 MONTH OLD DAUGHTER, BURNED 2 FINGERS ON HER LEFT HAND BY THE "VAPOR" RELEASED BY VAPORIZER. INSTRUCTIONS STATE TO KEEP CHILDREN AWAY FROM THE STEAM AS STEAM CAN CAUSE BURNS. INFANT WAS TREATED BY A DOCTOR FOR 2ND DEGREE BURNS. NO ADD'L INFO WILL BE RECEIVED. REPORT RECEIVED OF A PT DEATH DUE TO A RUPTURED PULMONARY ARTERY AFTER CATHETER PLACEMENT. THE PT WAS A 76-YR-OLD FEMALE WITH MITRAL VALVE DISEASE AND MILD PULMONARY HYPERTENSION. MONITORING LINES WERE PLACED PRE-OP FOR A MITRAL VALVE REPLACEMENT. AB OUT 5 MINS AFTER THE CATHETER WAS PLACED, THE PT BEGAN COUGHING UP BLOOD AND PROGRESSED TO CARDIOPULMANARY ARREST. FULL RESUSCITATIVE EFFORTS WERE NOT SUCCESSFUL. THE ANESTHESIOLOGIST WHO PLACED THE CATHETER HAD NOTED NO VISIBLE DEFECTS, THE CATHETER FELT SMOOTH, THE BALLOON INFLATED/DEFLATED WITHOUT DIFFICULTY AND THE CATHETER FLOATED INTO PLACE SMOOTHLY. THE CATHETER WEDGED "A LITTLE BEFORE EXPECTED" AT 52CM, BUT IT PERFORMED FINE WHEN WEDGED WITH THE BALLOON. THE CATHETER WAS DISCARDED AFTER BEING REMOVED FROM THE INTRODUCER TO ALLOW FOR FASTER FLOW OF RESUSCITATIVE MEDICATIONS AND BLOOD PRODUCTS. THE AUTOPSY INDICATED DEATH DUE TO PULMONARY HEMORRHAGE. LVAL296%r 744649960124SHERIDAN/CF TRACHEAL TUBEKENDALLKENDALL HEALTHCARE PRODUCTS THE DEVICE WAS USESD DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE LAPAROSCOPE WAS SECURED WITH THE SCOPE-LOCK; SURGEON PENETRATED THE ABDOMINAL WALL UNDER VISION. WHEN PENETRATING THE PERITONEUM THE OPTICAL LENS CAME OFF AND THE LAPAROSCOPE SLID INTO T HE ABDOMINAL CAVITY. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. THE OPTICAL LENS WAS NOT FOUND IN THE ABDOMINAL CAVITY. THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. BOTH SIDES OF THE STAPLELINE WERE BLEEDING. SURGEON ATTEMPTED TO CONTROL THE BLEEDING, AND THEN ELECTED TO CONVERT TO AN OPEN PROCEDURE TO COMPLETE CASE. THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY. THERE WAS A TROCAR PUNCTURE TO THE AORTA. CASE WAS CONVERTED TO AN OPEN PROCEDURE AND A VASCULAR SURGEON PERFORMED THE REPAIR. THE PT RECEIVED A BLOOD TRANSFUSION. THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THAT 4 DAYS POSTOPERATIVELY, PT DEVELOPED ABDOMINAL PAIN. PT WAS READMITTED TO A DIFFERENT HOSP AND A REOPERATION WAS PERFORMED, WHICH SHOWED 2 DISTALLY FORMED CLIPS ON THE CY STIC DUCT AND BILE LEAKAGE. THE PT REPORTEDLY EXPIRED DUE TO HEART FAILURE AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C063-10 AND 96-C064-7. THE PT REPORTEDLY EXPIRED DUE TO HEART FAILURE AND RENAL FAILURE. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C063-10 AND 96-C065-7. THE PT REPORTEDLY EXPIRED; HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. THE PT REPORTEDLY EXPIRED; HOWEVER, THE CAUSE OF THE DEATH IS UNKNOWN. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PT'S DEATH IS IMPLICATED. THE PT IN THIS REPORT IS THE SAME AS REPORTED IN 96-C0 88-10. LVALkT @ @ @THE DEVICE WAS IN USE ON A PT ITHE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY A CLIP SCISSORED AND SEVERED THE CYSTIC DUCT. SURGEON CONVERTED TO AN OPEN PROCEDRUE TO COMPLETE CASE. PT IS RECOVERING. STENT WAS SUCCESSFULLY PLACED IN THE PT'S RIGHT CORONARY ARTERY. FOLLOWING THE PROCEDURE, THE PT WAS TRANSFERRED TO THE CORONARY CARE UNIT. AT AN UNKNOWN POINT, THE PT ARRESTED AND EXPIRED. REPEATED ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT IN OR DER TO DETERMINE WHETHER THERE WAS ANY POSSIBILITY THAT A CAUSAL RELATONSHIP MAY HAVE EXISTED BETWEEN THE DEVICE AND THE EVENTS DESCRIBED ABOVE. CO WAS UNABLE TO OBTAIN THE INFO. AFTER APPLICATION OF THE BONE CEMENT, THE PT EXPERIENCED BRADYCARDIA WHICH LEAD TO CARDIOPULMONARY ARREST. RESUSCITATION MEASURES WERE ATTEMPTED AND UNSUCCESSFUL. (SEE DEN: 1008119.) AFTER APPLICATION OF THE BONE CEMENT, THE PT BECAME HYPOTENSIVE AND BRADYCARDIC. RESUSCITATION MEASURES WERE UNSUCCESSFUL. (SEE DEN: 1008120.) DURING AN INCIDENT CALL, THE OPERATORS ATTEMPTED TO APPLY THE ELECTRODE PADS TO THE PT, BUT THE LINER REPORTEDLY STUCK TO THE PADS AND WOULD NOT PROPERLY SEPARATE FROM THE ADHESIVE RING. THE OPERATORS TRIED A SECOND SET OF PADS WHICH ALSO WOULD NOT S EPARATE PROPERLY FROM THE LINER. THE OPERATORS APPLIED THE TORN PADS TO THE PT AND PERFORMED 3 DEVICE ASSESSMENTS WHICH RESULTED IN "NO SHOCK INDICATED" PROMPTS. AN ALS TEAM THEN ARRIVED AND ASSUMED PT CARE WITH ANOTHER DEFIBRILLATOR. THE PT WAS NOT RESUSCITATED. DURING AN INCIDENT CALL, THE DEVICE WAS APPLIED TO AN UNCONSCIOUS AND UNRESPONSIVE PT. REPORTEDLY, THE ALERT INDICATOR LIGHT FLASHED ON. THE PT WAS TRANSPORTED TO A HOSP AND WAS PRONOUNCED. THE COT FOLDED WHILE THE PT WAS ON THE COT, "CAUSING THE PT TO FALL BACKWARD. THE PT ALLEGES THAT THIS EVENT AGGRAVATED A PREVIOUS BACK INJURY." {LVAL)FA PT WITH A MULTIPLE ORGAN SYSTEM FAILURE WAS BEING DIALYZED IN A HOSP INTENSIVE CARE UNIT, WHEN HE WENT INTO VENTRICULAR TACHYCARDIA, AND WAS CODED. THE PT PROGRESSED TO CARDIAC ARREST, AND WAS NOT RESUSCITATED. THE CAUSE OF DEATH WAS LISTED AS CARD IAC ARREST. DURING THE ARREST, BLOOD WAS NOTED TO HAVE POOLED ON THE BED AT THE ACCESS SITE; ESTIMATED BLOOD LOSS WAS 500CC. EVENTS LEADING UP TO THE ARREST HAVE NOT BEEN CONFIRMED. THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. TWO DAYS POST-OPERATIVELY, PT WAS REOPERATED ON AND THE SURGEON NOTED THAT THE PROXIMAL 1/3 OF STOMACH WAS NECROSED. PT EXPIRED THE NEXT DAY. THE DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION THE DEVICE TORE THE STOMACH. THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY TO REPAIR THE TRAUMA. THE DEVICE WAS USED DURING A BOWEL PROCEDURE. POSTOPERATIVELY, THE PT DEVELOPED PERITONITIS AND EXPIRED. EMT'S RESPONDED TO A PERSON DESCRIBED AS IN CARDIAC ARREST. THE PT WAS CONNECTED TO THE DEVICE AND ANALYZED. TWICE, ACCORDING TO THE RPTR, THE DEVICE ADVISED SHOCKS AND CHARGED, BUT WOULD NOT TRANSFER ENERGY TO THE PT. A THIRD SHOCK WAS ADVISED AND D ELIVERED TO THE PT. SUBSEQUENT ANALYSES DID NO ADVISE A SHOCK. THE PT WAS NOT RESUSCITATED. ON 1/13/96 AN INFANT, BEING MONITORED, WAS LYING IN THE PRONE POSITION WITH AN UMBILICAL VESSEL CATHETER (UVC) INDWELLING WHEN THE MONITOR ALARMED SOUNDED. THE ATTENDING NURSE TURNED THE INFANT TO THE SUPINE POSITION AND NOTICED SOME BEEDINIG. THE EX CESS BLOOD WAS BLOTTED AND IT WAS NOTED THAT HALF OF THE CATHETER WAS IN AND THE OTHER HALF OF THE CATHETER WAS OUT. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER BUT WAS UNSUCCESSFUL. THE PT WAS SENT TO HOSP AND UNDERWENT A SURGICAL PROCEDURE IN ORDER TO REMOVE THE CATHETER. THE PT WAS RETURNED TO THE INITIAL HEALTH CARE FACILITY IN STABLE CONDITION. NO FURTHER INFO WAS PROVIDED. LVALsUg_ RK 744879960126RX PIGGYBACK WITH LAV VALVESABBOLABOABBOTT LABORATORIESDEATHNA190030448GEN HOSPITALFPAPTHE TUBING WAS DETACHED FROM THE VITRECTOMY CUTTER INCLUDED IN THIS PACK. NO PT INVOLVEMENT AS THE PROBLEM WAS FOUND DURING PREPARATION OF THE PACK PRIOR TO A PROCEDURE. DURING A CATARACT EXTRACTION PROCEDURE, THIS HANDPIECE FAILED TO ASPIRATE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY. RECEIVED CORRESPONDENCE FROM ATTY WHO STATED HIS CLINET'S WIFE WAS DIAGNOSED WITH TOXIC SHOCK SYNDROME AND DIED. THE PT WAS BEING FED THROUGH A NASOGASTRIC FEEDING TUBE USING A PUMP. AN ENTERAL FEEDING SOLUTION WAS HUNG, AND THE PUMP WAS SET TO DELIVER 40 ML/HR. NO FEEDING SOLUTION WAS DELIVERED OVER 8 HRS. THE PT HAD A SEVERE HYPOGLYCEMIC RESPONSE. TWO DOSES O F D50 WERE GIVEN. THE PT'S PRESENT CONDITION IS "FINE." FEMALE PT IS 74 YRS OLD. EVALUATION ANTICIPATED. OTHER RELEVANT HISTORY: FAILURE TO THRIVE AFTER OPEN HEART SURGERY, IDDM ACQUIRED SINCE ADMISSION TO THE HOSP BUT PRIOR TO THE EVENT. THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. WHEN THE DEVICE WAS FIRED, THE SURGEON "FELT A CRUNCH WITH A BIT OF A CATCH." THE DONUTS LOOKED GOOD, HOWEVER, THE ANASTOMOSIS FELL APART. UPON INSPECTION, IT WAS NOTED THAT THE STAPLES HAD NOT FOR MED PROPERLY. A COLO-ANAL ANASTOMOSIS AND TEMPORARY DIVERTING COLOSTOMY WERE PERFORMED. THE DEVICE WAS USED DURING A PNEUMONECTOMY. THE STAPLES DID NOT FORM AT THE TOP OF THE STAPLELINE, WHICH RESULTED IN AIR LEAKAGE. PT WAS "NEAR DEATH", REQUIRING ANOTHER SURGEON TO BE CALLED IN TO SUTURE THE SITE. THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. AFTER INSERTION OF A SECONDARY TROCAR, A LARGE VESSEL WAS STRUCK. CASE WAS CONVERTED TO AN OPEN PROCEDURE AND A VASCULAR SURGEON WAS CALLED IN TO REPAIR VESSEL. THE FEMALE LUER SEPARATED FROM ANTOHER MFRS DEVICE DURING USE. AS A RESULT OF THE SEPARATION, THE PT LOST BLOOD REQUIRING A TRANSFUSION. LVAL2|vpjd^XRLF@:4.(""A NEW TUBING WAS USED TO ESTABLISH A LEFT EXTERNAL JUGULAR IV SITE. WHILE PUSHING AN IV MEDICATION,DURING A TONSILLECTOMY PROCEDURE, THIS MOUTH GAG COULD NOT BE USED. THE SPRING ACTION WOULD NOT FUNCTION. THE PROCEDURE WAS DELAYED APPROX 10-15 MINS WHILE ANOTHER MOUTH GAG WAS PREPARED. NO PT INJURY. DURING SET UP PRIOR TO THE START OF AN OPHTHALMIC PROCEDURE, THE TUBING FROM THIS PACK WAS FOUND TO BE DEFECTIVE. NO PT INVOLVEMENT. DURING A CATARACT EXTRACTION PROCEDURE, THIS HANDPIECE WOULD NOT CALIBRATE AND IS LOSING POWER. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY. THREE STAFF NURSES CLAIM REPETITIVE MOTION INJURIES, (CARPAL TUNNEL AND NERVE). IT WAS REPORTED THAT THE INJURIES STEMMED FROM REPETITIVE MOTION USED IN OPENING (TWISTING, PUSHING, TAPPING) HARDPACK SYRINGES. THE NURSE(S) WERE PLACED UNDER DRS CARE A ND LIMITED TO LIGHT DUTY RESTRICTING FINE MOTOR MOVEMENTS. THE NURSE MGR STATED THAT SHE IS NOT SURE THAT OPENING THE HARDPACKS IS THE EXCLUSIVE CAUSE OF THE NURSES' COMPLAINT OF INJURY. SHE STATED THAT IT COULD ALSO BE DUE TO OTHER ACTIVITIES SUCH A S COMPUTER DATA ENTRY. THERE WAS NO MENTION OF MEDICAL TREATMENT OR INTERVENTION AND NO FURTHER COMPLICATIONS WERE REPORTED. DURING SET UP FOR AN EXAMINATION ON A FEMALE PT AGE 49 YRS FOR MAMMOGRAM-MEDIOLATERAL MAGNIFICATION, THE PATIENT'S BREAST WAS PINCHED WHEN THE MAGNIFICATION PLATFORM BELLY SHIELD RAISED UP, FOLDED ONTO THE TOP OF THE CASSETTE IN THE CASSETTE HOLDER A ND WAS REPOSITIONED BY THE OPERATOR WITHOUT MOVING THE PT. THE PT BECAME FAINT AND LOST COLOR. THIS INCIDENT OCCURRIED DUE TO THE MISUSE OF THE DEVICE BY THE OPERATOR. THE OPERATOR SHOULD HAVE MOVED THE PT FROM THE MAGNIFICATION PLATFORM WHILE SETTIN G UP FOR MEDILATERAL MAGINIFICATION. EXAMINATION OF IDENTICAL DEVICE SHOWED THE POSSIBILITY OF A PINCH IN THE EVENT OF A SIMILAR MISUSE. SHE WAS TREATED, RELASED AND CAME BACK FOR A MAMMOGRAM WITHIN A FEW WEEKS. LVAL% s WHILE USING THIS SYSTEM DURING A CATARACT EXTRACTION PROCEDURE, THE ASPIRATION MODE WOULD DESELECT. THE SYSTEM WAS USED TO COMPLETE THE PROCEDURE BY PRESSING THE IRRIGATION/ASPIRATION BUTTON. NO PT INJURY. THE SURGERY WAS DELAYED APPROX 10 MINS. DURING AN OPHTHALMIC PROCEDURE, THE BIPOLAR FUNCTION OF THIS MICROSURGICAL SYSTEM COULD NOT BE ACTIVATED. A BACK UP UNIT WAS USED. NO PT INJURY. THE UNIT WAS SERVICED AND THE FOOTPEDAL, WHICH WAS CRACKED AND FOUND TO HAVE A CRACKED BIPOLAR SWITCH, WA S REPLACED. THE VITRECTOMY CUTTER IN THIS PACK WOULD NOT FUNCTION. NO PT INVOLVEMENT AS THE PROBLEM WAS FOUND DURING PREPARATION OF THE PACK PRIOR TO A PROCEDURE. DURING ONE PROCEDURE, 2 CATHETERS ACCORDIONED DURING A SIMPLE PASSING OF THE CATHETERS OVER TWO GUIDEWIRES THROUGH A SCARRED GROIN. THEY BOTH ACCORDIONED BEFORE BEING ADVANCED THROUGH A SHEATH. ONE TIP ACTUALLY TORE. EXACT LOT NUMBER IS UNKNOWN. HOWE VER, A SHIP HISTORY REPORT FOR THE FACILITY REVEALED ONLY TWO SEPARATE LOTS. LOT HISTORY RECORDS WERE REVIEWED. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. EACH LOT WAS MFR TO SPECIFICATION AND PASSED ALL INSPECTIONS PRIOR TO REL EASE. CURRENT OPERATING REQUIRE THAT EACH CATHETER MFG BE INSPECTED BY MFR FOR THE FOLLOWING PARAMETERS: DISTAL TIP ID, THRU-LUMEN, PROXIMAL ID AND SHAFT. EACH OF THESE PARAMETERS ARE ALSO AUDITED BY THE QUALITY ASSURANCE DEPARTMENT. TWO CATHETERS WE RE RETURNED FOR EVALUATION AND BOTH SAMPLES MET DIMENSIONAL DISTAL TIP ID SPECIFICATIONS. UNABLE TO DETERMINE ANY MFG DEFICIENCIES. THE ANGIOGRAPHIC CATHETER INSTRUCTIONS FOR USE STATES; "NEVER ADVANCE ANGIOGRAPHIC GUIDEWIRE OR CATHETER AGAINST RESIS TANCE, AS THIS COULD CAUSE VESSEL TRAUMA AND/OR PRODUCT DAMAGE." POSSIBLE CAUSES OF THIS COMPLAINT: USER TECHNIQUE (DUE TO THE SOFTNESS OF THIS CATHETER'S TIP TECHNIQUE UPON INSERTION IS VERY IMPORTANT), RESISTANCE BETWEEN THE GUIDEWIRE AND THE CATHE TER INHIBITED ADVANCEMENT INTO THE PT (THE GUIDEWIRE WAS NOT RETURNED FOR EVALUATION). QLVALu}9i{puueUV4|pPDURING A CATARACT EXTRACTION PROCEDURE, THIS BIPOLAR CORD COULD NOT BE USED FOR THE CAUTERIZATION PHASE OF THE PROCEDURE. THE CORD WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. NO PT INJURY. "SMOKE" WAS SEEN COMING FROM THIS HANDPIECE BEFORE BEGINNING A CATARACT EXTRACTION PROCEDURE. THE HANDPIECE WAS EXCHANGED FOR ANOTHER. NO PT INJURY. SOLDER FAILURE ON HEATING ELEMENT TUBE ALLOWING HEATING ELEMENT TO CONTACT CASE CAUSING SMOKING. NO INJURY OR EVACUATION REPORTED. INSPECTION CONFIRMS SOLDER FAILURE. A SURGICAL PT HAD BEEN INTUBATED WITH THE REPORT DEVICE FOR OVER 5 HOURS. THE PT WAS MOVED FROM THE OR TO A POSTOP ICU. UPON ARRIVAL IN THE ICU THE REPORT DEVICE HAD ALLEGEDLY FLATTENED AGAINST THE PT'S PALLET. THE PT WAS EXTUBATED AND DID NOT REQUIR E A REINTUBATION. THE ACTUAL DEVICE IS NOT AVAILABLE FOR EXAMINATION. FAILURE INVESTIGATION CONSISTED OF A RECORDS' REVIEW OR THE REPORTED IN-STOCK LOT NUMBER. THE MFG RECORDS WERE FOUND TO BE ACCEPTABLE. THERE HAVE BEEN NO OTHER REPORTS OF ANY NATUR E RECEIVED FOR THIS LOT OF MATERIAL. DURING A CATARACT EXTRACTION PROCEDURE, THIS HANDPIECE FAILED TO ASPIRATE. IT WAS EXCHANGED FOR ANOTHER AND THE SECOND HANDPIECE WOULD NOT ASPIRATE. THE SERIAL NUMBER FOR THIS SECOND HANDPIECE IS NOT KNOWN. A THIRD HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY; HOWEVER, THE PROCEDURE WAS DELAYED APPROX 20 MINS. THE IRRIGATION PINCH VALVE OF THIS SYSTEM STUCK IN THE CLOSED POSITION DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE WHICH WAS DELAYED 15 MINS. NO PT INJURY. THE UNIT WAS SERVICED AND, ALTHOUGH NO PROBLEM C OULD BE FOUND WITH THE IRRIGATION PINCH VALVE, IT WAS REPLACED AS A PRECAUTIONARY MEASURE BECAUSE BSS (BALANCED SALT SOLUTION) WAS FOUND ON IT. DURING A CATARACT EXTRACTION PROCEDURE USING THIS HANDPIECE, THE PT REC'D A SHOCK. NO INJURY. THE HANDPIECE WILL BE RETURNED FOR EVAL. 4LVALD9DURING AN INCIDENT CALL INVOLVING AN 87 YR OLD PT, THE DEVICE RPORTEDLY DISPLAYED PROMPTS ON THE MONITOR WHICH THE OPERATORS DO NOT REMEMBER. CPR WAS ADMINISTERED AND ONE SHOCK WAS DELIVERED WHILE THE PT WAS BEING TRANSPORTED TO A HOSP. THE CUSTOMER STATED THAT HE FEELS THE DEVICE OPERATED PROPERLY, BUT IS CONCERNED THAT THE ELECTRODES WERE DEFECTIVE. THE DEVICE WAS USED DURING ANOTHER INCIDENT ON 12/15/95 AND FUNCTIONED PROPERLY. DURING AN INCIDENT CALL, THE DEVICE WAS APPLIED TO A 37 Y/O MALE PT IN FULL ARREST. THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS. THE OPERATOR SQUEEZED THE PAD TO CABLE CONNECTION TOGETHER WHICH CLEARED THE PROMPTS. THE DEVICE THEN DELI VERED FOUR SHOCKS TO THE PT. AN ALS TEAM THEN ARRIVED AND ASSUMED PT CARE. PT OUTCOME IS UNKNOWN. ALSO DURING TESTING BY THE CUSTOMER, THE DEVICE DISPLAYED "CHECK ELECTRODES" PROMPTS. DURING A MONITORING CALL IN TRANSIT TO A HOSP, THE DEVICE REPORTEDLY DISPLAYED "CHECK PT" PROMPTS THEN "NEEDS SERVICE-KEYBOARD" PROMPTS. THE DEVICE THEN REPORTEDLY DISPLAYED VERY IRREGULAR RHYTHMS. THE DEVICE WAS REMOVED FROM THE PT AND THE PRMPTS CL EARED. THE DEVICE WAS THEN POWERED OFF AND ON, AND SUCCESSFULLY PASSED ITS SELF TEST. THE CUSTOMER ALSO STATED THAT WHEN THE DEVICE IS NOT CONNECTED TO A PT, IT DISPLAYS IRREGULAR RHYTHMS. THE RETURNED DEVICE WAS INVESTIGATED AND ANALYZED BY A SERVIC E TECH, WHO VERIFIED PROPER OPERATION. IT WAS THOROUGHLY TESTED TO ALL DEVICE SPECIFICATIONS AND WAS FOUND TO BE FULLY COMPLIANT, OPERATING NORMALLY THROUGH ALL TESTS COMPLETED. FINALLY, SERVICE DEPT VERIFIED THE DEVICE'S CALIBRATION AND SUCCESSFULLY CONDUCTED A FUNCTIONAL ARRHYTHMIA TEST WITHOUT OBSERVING ANY PERFORMANCE DEVIATIONS OR IRREGULARITIES. THEREFORE, AS A RESULT OF CO INVESTIGATION AND SERVICE, CO BELIEVES THE DEVICE PERFORMS NORMALLY AND PROPERLY. THE RETURNED DEVICE WAS SUBJECTED T O A COMPREHENSIVE ANALYSIS AND EVALUATION WHICH VERIFIED ITS PROPER OPERATION AND PERFORMANCE. LVAL WWHEN CREATING A TREATMENT PLAN "ENTER BEAM #1 AND ENTER A CUSTOMIZED PORT FOR THAT BEAM USING TABLE OR MOUSE. THEN USE COPY PARALLEL OPPOSED TO CREATE BEAM #2. RETURN TO BEAM #1 AND EDIT CUSTOMIZED PORT. WHEN SELECTING "DONE" TO RECALCULATE DOSE, BEA M #1 IS RECALCULATED BUT BEAM #2 IS NOT". CHANGE IN PORT NOT NOTICED. IF PLAN WERE SAVED AND THEN RECALLED, DOSE CALCULATIONS WOULD BE CORRECT. CUSTOMER SUPPORT ASKED USER TO TRY SAVING THE PLAN AFTER BEAM #1 CUSTOMIZED PORT WAS MODIFIED THEN RECALLI NG THE PLAN. WHEN THIS WAS DONE, BOTH BEAMS NOW HAD CORRECT DOSE VALUES DISPLAYED. CO INITIATED COMPLAINT F171 TO CAPTURE PROBLEM & ITS INVESTIGATION & RESOLUTION.CO DEVELOPMENT WAS ABLE TO DUPLICATE PROBLEM FOLLOWING STEPS GIVEN BY USER. INVESTIGATI ON OF PROBLEM FOUND ITS ROOT CAUSE TO BE AN INCOMPLETE REQUIREMENTSPEC. SITUATION WHERE A CUSTOMIZED PORT WAS MODIFIED DID NOT CALL FOR IMMEDIATELY RECALCULATING DOSE FOR ALL OTHER BEAMS WHICH USED SAME CUSTOMIZEDPORT ID AS THAT OF THE MODIFIED BEAM WHEN "DONE" WAS SELECTED. AS A RESULT, ONLY THAT BEAM WHICH HAD ITS CUSTOMIZED PORT MODIFIED RECALCULATED DOSE USINGTHE STEPS NOTED EARLIER. ANY SUBSEQUENT CHANGE TO THESE BEAMS WOULD IN FACT RECALCULATE USING THE CORRECT PORT SHAPES. THE EFFECT ON D OSE CALCULATIONS ISIMPOSSIBLE TO PREDICT BECAUSE OF THE INFINITE VARIETY OF DIFFERENT MODIFICATIONS POSSIBLE TO A CUSTOMIZED PORT. SITUATION WHICH LED TO THIS BEING CONSIDERED AN MDR SITUATION WAS CASE WHERE THE CHANGE IS SOMEWHERE IN BETWEEN THE 2 E XTREMES NOTED. IT COULD POSSIBLY RESULT IN A DOSE CALCULATION WHICH WOULD BE LARGE ENOUGH TO CAUSE SERIOUS PT INJURY WHILE AT THE SAME TIMEBE SMALL ENOUGH TO GO UNNOTICIED BY USER. NO VALUES WERE DETERMINED FOR THIS IN BETWEEN STATE BUT ITS POSSIBILI TY WAS CONFIRMED. THIS PROBLEM HAS BEEN FIXED IN NEW SOFTWARE WHICH WILL BE PROVIDED TO ALL CUSTOMERS, FREE OF CHARGEIN 1/96. PROBLEM HAS BEEN ADDED TO CO PUBLICATION (A LIST OF KNOWN BUGS IN SYSTEM, PUBLISHED & MAILED FREE OF CHARGE TO ALL USERS ON A MONTHLY BASIS) TOALERT UoLVAL{.w7UUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUIT WAS REPORTED THAT THE DEVICE WAS USED DURING A BILATERAL TUBAL LIGATION. THE SURGEON A DRYER THERMOSTAT IS TRIPPING, CAUSING WET FILMS, WHICH ARE NOT READABLE. DURING AN INCIDENT CALL INVOLVING AN 93 YEAR OLD FEMALE PT IN CARDIAC ARREST, THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHANGED THE PADS AND THE BATTERY, BUT THE PROMPTS DID NOT CLEAR. FIRE DEPARTMENT PERSONNEL ON SCEN E THEN STATED THAT THEIR DEFIBRILLATOR HAD ALSO GIVEN CHECK ELECTRODES MESSAGES WHEN THEY ATTEMP853297MED DEVICE960125STORZ MICROSEAL STAINLESS STEEL PHACOEMULSIFICATIOSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP8040NAOPHTHALMICHQCF@RxvpeQI861363MED DEVICE960129LIFEPAK DEFIBRILLATOR QUIK-PACE EXTERNAL NONINVASIPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION8802904-04CARDIOVASCULARLDDF!@zqpeQI861352MED DEVICE960130THREE WAY STOPCOCK WITH FIXED MALE LUER LOCKMEDEXMEDEX, INC.MALFUNCTIONNAMX531-FLGEN HOSPITALFMGF@xwth`^SHC861351MED DEVICE960130DISPOSABLE VOLUMETRIC INFUSION PUMP SETMEDEXMEDEX, INC.MALFUNCTIONNAIV3D10GEN HOSPITALFPAF@}}qpma[YNC>861343MED DEVICE960130LIFE DEFENSE PLUSMATRMEDIMATRX MEDICAL, INC.MALFUNCTIONNA91140500CARDIOVASCULARLDDFz@vvjifXPNC0(861339MED DEVICE960130LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKERPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION10804200-14CARDIOVASCULARLDDF@@~pgeZF>861337MED DEVICE960130LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKERPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION9P805460-01CARDIOVASCULARLDDF@~pgeZF>861329MED DEVICE960130LIFE DEFENSE PLUSMATRMEDIMATRX MEDICAL, INC.MALFUNCTIONNA91140500CARDIOVASCULARLDDF@vvjifXPNC0(860988MED DEVICE960205SOFT-VU FLUSH SERS TO PROBLEM & HOW TO AVOID IT. A SPECIAL VALIDATION TEST CASE HAS BEEN ADDED TO LOOK FOR THIS PROBLEM & AVOID ITS RECURRENCE.LVALurg<^rpTHE SCOPE WOULD NOT ANGULATE DURING THE PROCEDURE CAUSING THE COLONOSCOPY TO BE DISCONTINUTED IN ORDER FOR THE SCOPE TO BE REMOVED. A SECOND SCOPE WAS USED TO COMPLETE THE PROCEDURE. CO IS INVESTIGATING THE CAUSE OF THE PROBLEM. PROCEDURE WAS INITIATED WITH OUT INCIDENT, HOWEVER, WHEN REMOVING THE CATHETER WITH THE WIRE IN THE PT, THERE WAS MUCH RESISTANCE. WHEN THE CATHETER WAS FINALLY REMOVED, THE PHYSICIAN NOTICED THE BLACK TIP WAS DAMAGED. AFTER REMOVING THE WIRE FORM TH E PT THE PHYSICIAN SAW THE REMAINING PORTION OF THE CATHETER MATERIAL ON THE GUIDEWIRE. EACH OF THE LOT HISTORY RECORDS WERE REVIEWED FOR ANY ABNORMALITIES WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING UNUSUAL WAS OBSERVED. EACH LOT WAS MANUFA CTAURED TO SPEC AND PASSED ALL INSPECTIONS PRIOR TO RELEASE. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. A RETAIN SAMPLE WAS NOT AVAILABLE. INSTRUCTIONS FOR USE STATES: CATHETERS ARE DESIGNED FOR USE WITH SPECIFIC GUIDEWIRE DIAME TERS. THE RECOMMENDED (MAXIMUM) GUIDEWIRE DIAMETER IS SPECIFIED ON THE CATHETER LABEL. THESE INSTRUCTIONS ALSO STATE: "NEVER ADVANCE AN ANGIOGRAPHIC GUIDEWIRE OR CATHETER AGAINST RESISTANCE, AS THIS COULD CAUSE VESSEL TRAUMA AND/OR PRODUCT DAMAGE." DURING A CATARACT EXTRACTION PROCEDURE, THIS SYSTEM EXHIBITED LOW ASPIRATION. THE SYSTEM WAS USED FOR THE PROCEDURE AND THERE WAS NO PT INJURY; HOWEVER, THE PROCEDURE WAS DELAYED APPROX 15 MINS. A SERVICE CALL WAS PLACED FOR THIS SYSTEM AND NO PROBLE M WAS FOUND. THE CONTACT FEELS THE PROBLEM MAY HAVE BEEN CAUSED BY THE PHYSICIAN NOT PUSHING DOWN ON THE FOOT PEDAL ALL THE WAY. THIS PAIR OF FORCEPS WERE REPORTED TO BE LOCKING UP DURING A PROCEDURE AND COULD NOT BE USED. NO PT INJURY, HOWEVER, THE PROCEDURE WAS DELAYED APPROX 15 MINS WHILE REPLACEMENT FORCEPS WERE FOUND. THE FORCEPS WERE RETURNED AND FOUND TO BE IN NEED OF L UBRICATION. LVALT}9ic?7 853310960125STORZ MVS ANTERIOR VITRECTOMY PACKSTODURING A CATARACT EXTRACTION PROCEDURE, THIS BAMBULANCE PERSONNEL ATTENDED TO A LARGE PT WITH A LONG HISTORY OF HEART PROBLEMS. THE PT WAS DIAGNOSED TO BE IN VENTRICULAR FIBRILLATION AND ONE ATTEMPT WAS MADE TO DEFIBRILLATE AT 200 JOULES. THE PT WAS NOT CONVERTED. REPORTEDLY EXTERNAL PACING WAS INITIATED AND CAPTURE WAS ACHIEVED WITH THE PACING ELECTRODES PLACED IN THE ANTERIOR/POSTERIOR POSITION. DURING TRANSPORT TO THE HOSP, PACING WAS INTERRUPTED AND THE LEADS OFF ALARM SOUNDED. AN ATTEMPT WAS MADE TO REINITIATE PACING HOWEVER THE UNIT C ONTINUED TO DISPLAY THE LEADS OFF ALARM. NO FURTHER ATTEMPTS WERE MADE TO RESUSCITATE DUE TO THE PTS LACK OF VIABILITY. THE OPERATOR LATER INDICATED HE DID NOT VERIFY PROPER CONNECTION BETWEEN THE PACING CABLE AND THE POSTERIOR PACING ELECTRODE. CO E VALUATED THE UNIT AND PROPER OPERATION WAS OBSERVED DURING PERFORMANCE AND FUNCTIONAL TESTING. THE UNIT WAS RETURNED TO THE CUSTOMER. COLONOSCOPY WAS PERFORMED ON A PT WHO SUBSEQUENTLY HAD TO BE READMITTED TO THE HOSP DUE TO A COMPLAINT OF ABDOMINAL PAIN. X-RAYS REVEALED A SMALL TEAR IN THE COLON AND ALTHOUGH SURGERY WAS NOT REQUIRED TO REPAIR THE TEAR, THE PT RECEIVED TREATMENT TO CORRECT THE PROBLEM. THE PT HAD BEEN ADMITTED TO THE HOSP WITH A PRE-EXISTING CONDITION OF DIVERTICULITIS. CO WILL NOT PERFORM AN EVALUATION OF THE ENDOSCOPE SINCE HOSP PERSONNEL PERFORMED A VISUAL AND MANUAL INSPECTION AND CONCLUDED THAT THERE WERE NO PROBLEMS WITH THE SCOPE. THE ENDOSCOPE HAS BEEN RETURNED TO SERVICE. PERFORATION OF THE COLON OCCURRED DURING COLONOSCOPY. THE PT HAD A PRE-EXISTING CONDITION OF COLITIS AND RECTAL BLEEDING AND AFTER THE PERFORATION WAS REPAIRED, THE PT WAS REPORTED TO BE IN STABLE CONDITION. CO WILL NOT PERFORM AN EVALUATION OF THE E NDOSCOPE SINCE HOSP PERSONNEL PERFORMED A VISUAL AND MANUAL INSPECTION AND CONCLUDED THAT THERE WERE NO PROBLEMS WITH THE SCOPE. THE ENDOSCOPE HAS BEEN RETURNED TO SERVICE. LVAL [THE PLASTIC COLLAR AT THE JUNCTION WHERE THE PUMP CONNECTS TO THE ARTICULATING ARM CRACKED AND THE PUMP FELL OFF THE CEILING MOUNT, PULLING THE CATHELER OUT OF THE PT'S ARM. IT ALSO FELL ON THE TECHNOLOGIST'S FOOT, FRACTURING HER TOE. FEMALE PT'S AGE IS 72, WEIGHT: 125 LBS. THE COMPLAINT SAMPLE (THE INJECTOR HEAD, THE INJECTOR MOUNTING ARM AND THE PLASTIC ENGAGEMENT COLLAR) RETURNED FOR EVAL. THE FOLLOWING OBSERVATIONS WERE MADE: THE CAUSE OF THE FALLEN INJECTOR HEAD WAS SEPARATION OF THE INJECT OR MOUNTINGARM FROM THE ARTICULATING ARM AS A RESULT OF A BROKEN RETAINING COLLAR. THE RETAINING COLLAR WAS FOUND TO BE CRACKED AXIALLY A LONG ITS ENTIRE LENGTH. ADDITIONALLY, A RETAINING CLIP WAS ALSO BROKEN AND MISSING FROM THE RETURNED PART. EXAMI NATION OF THE RETURNED MOUNTING ARM REVEALED THAT SCREWS USED TO ASSEMBLE THIS STRUCTURE WERE TAMPERED WITH IN THE FIELD. TWO OF THE THREE FASTENERS USED TO SECURE THE MOUNTING ARM'S END ADAPTER TO ITS TUBE WERE LOOSE AND THEIR HEX SLOTS WERE SEVEREL Y WORN. BOTH OF THESE FASTENERS WERE PART OF THE ORIGINAL ASSEMBLY MFG BY CO. THE THIRD FASTENER USED TO SECURE WAS REPLACED WITH A SUBSTITUTE OF UNSPECIFIED AND UNKNOWN SOURCE IN THE FIELD. THIS STYLE FASTENER IS NOT USED IN PRODUCTION AT CO FOR ANY OF ITS PRODUCTS, SO ITS APPEARANCE IN THIS APPLICATION IS HIGHLY LIKELY TO HAVE BEENCAUSED BY THE USRE. THE INDICATING WHEEL ON THE RETURNED INJECTOR HEAD WAS ALSO DAMAGED. THIS IS THE MOST LIEKLY POINT OF PRIMARY IMPACT WITH THE FLOOR,SINCE THE STE EL BALL SCREW SHAFT TO WHICH THE INDICATING WHEEL IS ATTACHED ISBENT. A NEW ARTICULATING ARM WAS PROVIDED BY ONE OF CO'S MFR DISTRIBUTORS. ITIS SUPPLIED WITH A MACHINED ALUMINUM RETAINING COLLAR WHICH SECURES THE SEMILUNAR RETAINING PAWL INTO THE ART ICULATING ARM WITH A SET SCREW RATHER THAN A FLEXIBLE LOCKING CLIP. IT OFFERS A SUPERIOR ALTERNATIVE TO THE PRESENTINJECTED MOLDED PLASTIC DESIGN IN THE FIELD. THE ALUMINUM COLLAR IS LESS LIKELY TO BE DAMAGED AS A RESULT OF FIELD ABUSE AND TAMPERING. CO WILL BE UPGRADING ALLVALfv@$I$I$DURING THE LAST THREE INCIDENT CALLS, THE DEVICE DISPLAYED CONTINUOUS "CHECK ELECTRODES" PROMPTS. THE PTS WERE NOT DIAPHORETIC. THE CUSTOMER ALSO STATED THAT THE PADS WERE SECURELY ADHERED TO PTS. PT OUTCOMES ARE UNKNOWN. THE FLUSH DEVICE CONTINUES TO FAST FLUSH AFTER IT SHOULD NOT. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE REPORTER STATED THAT THIS HAD OCCURRED ON MULTIPLE OCCASIONS BUT DID NOT PROVIDE DETAILS ON OTHER EVENTS. CAUTERY PENCIL WORKED INTERMITTENTLY. CAUTERY PENCIL WORKED INTERMITTENTLY. A WATER INLET SOLENOID HAD FAILED TOSHUT OFF COMPLETELY, ALLOWING WATER TO PASS THROUGH INTO THE BICARBONATE MIX TANK UNEXPECTEDLY ON 2 OCCASIONS. THE FIRST OCCASION WAS UNREPORTED UNTIL THE TIME OF THIS REPORT. ON THE SECOND OCCASION, THE WATER LEAK ED INTO THE MIX TANK DURING A TREATMENT SESSION. THIS LEAKAGE CAUSED A DILUTION OF THE BIRCARB SOLUTION, WHICH, WHEN DELIVERED TO THE DIALYSIS MACHINES, CAUSED THEM TO GO INTO "ALARM MODE" FROM A LOW CONDUCTIVEITY OR LOW PH READING. THOUGH THERE WAS NO INJURY, PTS' TREATMENT WAS DELAYED OR ENDED EARLY WHILE A NEW BATCH OF BICARBONATE SOLUTION WAS MIXED. A RECURRENCE OF THIS MALFUNCTION IS UNLIKELY TO CUASE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, UNLESS A DIALYIS SMACHINE WERE TO EXPERIENCE M ULTIPLE SIMULTANEOUS FAILURES. THE USER FACILITY WAS ADVISED TO REPLACE THE SOLENOID. TEH MACHINE WAS OUT OF WARRANTY, AND THE FAILURE OF THIS SOLENOID CAN BE EXPECTED, WITH PROLONGED USE. THE FACILITY IS RESPONSIBLE FOR MAINTENANCE OF THE MACHINERY, AND SHOULD HAVE REPLACED THE SOLENOID AT THE FIRST INDICATION OF MALFUNCTION DURING AN OPHTHALMIC PROCEDURE, PARTICULATE CAME FROM THIS HANDPIECE ONTO THE SURFACE ON THE PT'S EYE. THE PARTICULATE WAS WASHED FROM THE EYE. NO PT INJURY. PARTICULATE MAY HAVE COME FROM THISL ARTICULATING ARMS IN SVC WITH THE NEW RETAINING COLLAR IN 1/96.LVAL$SPdTHE PLASTIC COLLAR AT THE JUNCTION WHERE THE PUMP CONNECTS TO THE ARTICULATING ARM CRACKED AND THE UNIT FELL OFF THE CEILING MAINT, FRACTURING THE TECHNOLOGIST'S TOE. AS THE PUMP FELL, IT ALSO PULLED THE CATHETER OUT OF THE PT'S ARM. FEMALE PT'S AGE IS 41, WEIGHT: 225 LBS.THE COMPLAINT SAMPLE (THE INJECTOR HEAD, THE INJECTOR MOUNTING ARM AND THE PLASTIC ENGAGEMENT COLLAR) WAS RETURNED FOR EVAL. THE FOLLOWING OBSERVATIONS WERE MADE. THE CAUSE OF THE FALLEN INJECTOR HEAD WAS SEPARATION OF THE INJE CTOR MOUNTING ARMFROM THE ARTICULATING ARM AS A RESULT OF A BROKEN RETAINING COLLAR, THE RETAINING COLLAR WAS FOUND TO BE CRACKED AXIALLY LONG ITS ENTIRE LENGTH. ADDITIONALLY, A RETAINING CLIP WAS ALSO BROKEN AND MISSINGFROM THE RETURNED PART. EXAMIN ATION OF THE RETURNED MOUNTING ARM REVEALED THAT SCREWS USED TO ASSEMBLE THIS STRUCTURE WERE TAMPERED WITH IN THE FIELD. TWO OF THE THREE FASTENERS USED TO SECURE THE MOUNTING ARM'S END ADAPTER TO ITS TUBE WERE LOOSE AND THEIR HEX SLOTS WERE SEVERELY WORN. BOTH OF THESE FASTENERS WERE PART OF THE ORIGINAL ASSEMBLY MFR BY CO. THE THIRD FASTENER USED TO SECURE THIS JOINT WAS REPLACED WITH A SUBSTITUTE OF UNSPECIFIED AND UNKNOWN SOURCE IN THE FIELD. THIS STYLE FASTENER IS NOT USED IN PRODUCTION AT CO FOR ANY OF ITS PRODUCTS, SO ITS APPEARANCE IN THIS APPLICATION IS HIGHLY LIKELY TO HAVE BEEN CAUSED BY THE USER. THE INDICATING WHEEL ON THE RETURNED INJECTOR HEAD WAS ALSO DAMAGED. THIS IS THE MOST LIKELY POINT OF PRIMARY IMPACT WITH THE FLOOR, S INCE THE STEEL BALL SCREW SHAFT TO WHICH THE INDICATING WHEEL IS BENT. A NEW ARTICULATING ARM WAS PROVIDED BY ONE OF CO'S MFR DISTRIBUTORS. IT IS SUPPLIED WITH A MACHINED ALUMINUM RETAINING COLLAR WHICH SECURES THE SEMILUNAR RETAINING PAWL INTO THE A RTICULATING ARM WITH A SET SCREW RATHER THAN A FLEXIBLE LOCKING CLIP. IT OFFERS A SUPERIOR ALTERNATIVE TO THE PRESENTINJECTED MOLDED PLASTIC DESIGN IN THE FIELD. THE ALUMINUM COLLAR IS LESS LIKELY TO BE DAMAGED AS A RESULT OF FIELD ABUSE AND TAMPERIN G.1LVALA  A TEAR WAS FOUND IN THE BLUE DISTAL (BRONCHIAL) CUFF. THE DEVICE WAS RETURNED. THE DEVICE SHOWS SIGNS OF BEING USED; A WHITE DRIED SUBSTANCE COATS THE INSIDE OF THE TRACHEAL LUMEN. BECAUSE OF THIS, THE DEVICE MUST BE RESTERILIZED AND A SUPPLEMENTAL R EPORT WILL BE FILED AT THE CONCLUSION OF THE INVESTIGATION. A VISUAL INSPECTION AND INFLATION OF THE DISTAL CUFF PRIOR TO DECONTAMINATION REVEALS A STRAIGHT SLICE IN ONE OF THE FOLDS OF THE CUFF MATERIAL. THIS SLICE IS IN THE CTR OF THE CUFF BODY AND ON THE DISTAL TUBE SIDE. THAT IS THE CENTRAL WALL OF THE MAIN TUBE BODY. THE LOT NUMBER IS UNKNOWN AT THIS TIME, BUT THIS INFO HAS BEEN REQUESTED. TUBE WAS USED ON A PT IN ICU AND WHEN THE PT BIT THE TUBE, IT COLLAPSED THE TUBE LUMEN AND BLOCKED THE TUBE COMPLETELY. THE DEVICE WAS RETURNED IN A SEALED POUCH WHICH WAS USED TO RE-STERILIZE THE PRODUCT AT THE USER FACILITY. VISUAL INSPECTION CONFI RMS THAT THE TUBE BODY HAS BEEN PERMANTLY DEFORMED IN SEVERAL AREAS ALONG THE TUBE, AND AT THE 14CM MARK, THE AIRWAY IS NO LONGER PATENT HAVING COMPLETELY COLLAPSED WHEN DEFORMED. THERE IS SOME DELAMINATION AT THIS LOCATION, BUT THIS IS EITHER DUE TO THE FORCE OF THE PT BITING ON THE TUBE OR AN IMPROPER RESTERILIZATION CYCLE. WITHOUT A LOT NUMBER, PRODUCTION RECORDS AND RETAINED UNIT ANALYSIS COULD NOT BE PERFORMED. NO MFG ERROR HAS OCCURRED; THE PT SIMPLY BIT DOWN WITH A FORCE GREATER THAN THE DESIGN OF THE TUBE IS CAPABLE OF WITHSTANDING. NO FURTHER INFO IS ANTICIPATED. THE LIGHT SOURCE COMPONENT ARCED AS IT TURNED ON. THE ARCING OCCURRED PRIOR TO THE PROCEDURE AND THE SURGICAL INSTRUMENT TECH CLAIMS THAT THE ARC TRAVELED 3 INCHES UP HER LEFT WRIST AREA AND LEFT A RED BURN MARK. SHORTLY AFTER, SHE EXPERIENCED TINGLI NG IN HER LEFT ARM AND RIGHT LEG. THE TECH WAS TREATED AND ADMITTED FOR CHANGES IN HER EKG. AT THIS TIME, HOSP PERSONNEL ARE NOT SURE IF THE ELEVATED EKG WAS A PRE-EXISTING CONDITION. CO WILL EVALUATE THE DEVICE WHEN IT BECOMES AVAILABLE. LVALkWHEN CREATING A TREATMENT PLAN "ENTER BEAM #1 AND ENTER A CUSTOMIZED PORT FOR THAT BEAM USING TABLE OR MOUSE. THEN USE COPY PARALLEL OPPOSED TO CREATE BEAMDURING A CATARACT EXTRACTION PROCEDURE, THE PHYSICIAN RECEIVED A SHOCK WHILE USING THIS HANDPIECE. THE HANDPIECE WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS THEN COMPLETED. NO INJURY. WHEN THE CLINICIAN CHECKED THE CUFF INFLATION SYSTEM OF THE INDICATED DEVICE PRIOR TO INTUBATION, AN AIR LEAK WAS FOUND IN THE BLUE DISTAL (BRONCHIAL) CUFF. THE DEVICE WAS RETURNED. THE POUCH IN WHICH IT WAS RETURNED SHOWED NOT SIGNS OF DAMAGE TO THE TOP OR BOTTOM WEBS. INFLATION OF THE DISTAL CUFF OF THE DEVICE CONFIRMS THAT THERE IS A CUFF LEAK. MICROSCOPIC EXAM OF THE DISTAL CUFF REVEALS A SMALL STRAIGHT SLICE MEASURING 0.6MM LONG, LOCATED 1.7MM FROM THE CUFF'S DISTAL SHOULDER. THE SLICE IS I N LINE WITH THE PRINTING ON THE TUBE BODY. IN THIS CONDITION, THIS DEVICE COULD NOT PASS 100% 4 HR INFLATION SYSTEM TEST PERFORMED AT FINISHED DEVICE INSPECTION AND WOULD BE DISCARDED. PRODUCTION RECORDS FOR THIS LOT WERE REVIEWED; NO DEVICE WITH HOL ES IN CUFFS WERE FOUND DURING THE 100% INFLATION TEST, AND NO PROBLEMS WERE INDICATED DURING THE MFR OF THE CUFFS; ALL CUFF DIMENSIONAL READINGS WERE WELL WITHIN SPECIFICATIONS. THIRTEEN RETAINED UNITS FOR THIS LOT WERE 4 HR INFLATE TESTED POST-STERI LE AND FOUND FULLY FUNCTIONAL. A COMPLAINT FILE REVIEW REVEALED NO PRIOR COMPLAINTS INVOLVING THE DEVICE LOT OR ITS SUBCOMPONENTS' LOTS. BASED ON THIS INFO AND EXAM RESULTS, IT CAN ONLY BE CONCLUDED THAT THE CUFF WAS DAMAGED BY A SHARP EDGE ENCOUNTER ED IN 1 OR 2 TIME PERIODS: AFTER FINISHED DEVICE INSPECTION AND BEFORE SEALING THE PACKAGE AT CO, OR AFTER THE USER OPENED THE PACKAGE AND BEFORE THE USER'S INFLATION TEST. IT SHOULD BE NOTED THAT NO SHARP INSTRUMENTS ARE USED DURING PACKAGING OF THI S PRODUCT, BUT THE EXACT CAUSE CANNOT BE DETERMINED. NEVERTHELESS, BECAUSE THERE ARE NO OTHER REPORTS OF THIS DAMAGE FOR THIS LOT,IT IS BELIEVED THAT THIS WAS AN ISOLATED EVENT. LVALAN ANESTHESIOLOGIST INTUBATED A PT WITH ONE OF THE INDICATED DEVICES (NOT STATED WHICH ONE) BUT AFTER 15 MINS, AIR LEAKAGE WAS APPARENT. THE DR ATTEMPTED TO REINTUBATE BUT WITH THE SAME RESULT. THE DR THEN REINTUBATED WITH A TUBE OF THE BRAND SHE CUR RENTLY USED ON A REGULAR BASIS. AND NO FURTHER PROBLEMS OCCURRED. IN A SECOND CASE, THE SAME ANESTHESIOLOGIST ENCOUNTERED A SIMILAR PROBLEM. THE DEVICES WERE NOT RETURNED. PRODUCTION RECORDS WERE REVIEWED. FOR BOTH LOTS, NO PROBLEMS WITH CUFF MFR WER E ENCOUNTERED. ALSO IN BOTH LOTS, SOME UNITS WERE FOUND TO HAVE INFLATION SYS DEFECTS DURING THE 100% FOUR HR INFLATION SYS TEST PERFORMED AT FINISHED DEVICE INSPECTION, BUT THESE QUANTITIES WERE WELL BELOW THE THRESHOLD QUANTITIES FOR EACH DEFECT TY PE AND WERE THUS CONSIDERED NORMAL YIELD LOSS. FOR THE LOT OF CATALOG NO. 5-12614, IT WAS NOTED PRIOR TO INSPECTION THAT A PROBLEM OCCURRED WITH INADEQUATE TIP MELTING, BUT THE SMALL AMOUNT (6) OF DISCREPANT UNITS WERE SCRAPPED AND NO SUBSEQUENT MELT PROBLEMS WITH THE LOT WERE FOUND AT FINISHED DEVICE INSP (AS STATED ABOVE). FIVE RETAINED UNITS FOR CATALOG NO. 5-12615 & THIRTEEN RETAINS FOR CATALOG NO.5-12614 WERE TESTED AFTER STERILIZATION BY FOUR HR LEAK TESTING, & ALL WERE FOUND FULLY FUNCTIO NAL. A COMPLAINT FILE REVIEW OF EACH LOT & THEIR RESPECTIVE SUB- COMPONENTS' LOTS FOUND NO PRIOR COMPLAINTS FOR ANY LOT. FURTHER, NO OTHER REPORTS OF CUFF LEAKS IN THIS DEVICE TYPE HAVE BEEN FILED IN ALL OF 1995. BASED ON THIS INFO, THE FACT THAT THE TUBES WERE INITIALLY FUNCTIONAL, THE BRAND WAS NEW TO THE USER, & THERE IS NO SAMPLE TO EXAMINE, IT CAN ONLY BE CONCLUDED THAT THE CAUSE OF THE APPARENT LEAKAGE WAS ENCOUNTERED DURING USE; NO EVIDENCE TO SUPPORT A MFG ERROR HAS BEEN FOUND. IT IS POS SIBLE THAT BECAUSE THE USER WAS NOT USED TO THIS BRAND, THE CLINICAN DID NOT FULLY INFLATE THE CUFF, WHICH WOULD ALLOW AIR TO ESCAPE AROUND IT MISLEADING THE USER TO CONCLUDE THAT THE DEVICE HAD MALFUNCTIONED. THE EXACT CAUSE, HOWEVER,CANNOT BE DETER MINED.3LVAL4CUg_[THIS OSTEOTOME BROKE DURING A NASAL PROCEDURE AND THE BROKEN PIECE REMAINS IN THE PT'S NOSE. THE CONTACT IS UNAVAILABLE FOR ADD'L INFO CONCERNING THIS EVENT UNTIL 1/8/96. ATTEMPTS WILL BE MADE AT THAT TIME TO OBTAIN ADD'L PT INFO. IF THIS INFORMATION INDICATES THAT ADD'L SURGERY WILL BE PERFORMED TO RETRIEVE THE BROKEN PIECE OF INSTRUMENT, THIS REPORT WILL BE UPDATED ACCORDINGLY. A HAIR WAS PRESENT IN THE UNOPENED PACKAGE OF THE REPORT DEVICE. THE PRODUCT WAS NOT USED ON A PT. THE RETURNED DEVICE WAS EXAMINED AND CONFIRMS THE REPORT. THE DEVICE HISTORY FILES INDICATE NO PROBLEMS WERE ENCOUNTERED DURING PACKAGING AND TO DATE T HERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE RECEIVED FROM THE FIELD. THIS APPEARS TO BE AN ISOLATED EVENT. CHIEF ANESTHESIOLOGIST OPENED A NEW PACKAGE AND INFLATED THE BALLOON. "THE BUGS OCCURRED IMMEDIATELY AND THE BALLOON DEFECTED VERY QUICKLY." IT IS ASSUMED THAT THE CUFF LEAKED UPON INFLATION. THE DEVICE WAS NOT RETURNED FOR EXAMINATION. PRODUCTION RE CORDS WERE REVIEWED. NO PROBLEMS IN CUFF MFR WERE ENCOUNTERED. WHILE SOME UNITS WERE FOUND TO HAVE INFLATION SYSTEM DEFECTS DURING THE 100% FOUR HR INFLATION SYSTEM TEST PERFORMED AT FINISHED DEVICE INSPECTION, THESE QUANTITIES WERE WELL BELOW THE TH RESHOLD QUANTITIES FOR EACH DEFECT TYPE AND WERE THUS CONSIDERED NORMAL YIELD LOSS. FIVE RETAINED UNITS WERE TESTED AFTER STERILIZATION BY FOUR HR LEAK TESTING, AND ALL WERE FOUND FULLY FUNCTIONAL. A COMPLAINT FILE REVIEW OF THIS LOT AND ITS SUB-COMP ONENTS' LOTS SHOWED NO PRIOR COMPLAINT INVOLVEMENT. FURTHER, NO OTHER REPORTS OF CUFF LEAKS IN THE DEVICE TYPE HAVE BEEN FILED IN ALL OF 1995 (EXCEPT FOR 95-12-082 WHICH WAS FILED BY THE SAME DISTRIBUTOR AT THE SAME TIME AS THIS REPORT). BASED ON THI S INFO THERE IS NO EVIDENCE TO SUPPORTTHAT A MFG ERROR OCCURRED, BUT WITHOUT EXAMINING THE ACTUAL DEVICE INVOLVED, THE CAUSE OF THE APPARENT CUFF LEAK CANNOT BE DETERMINED. NO FURTHER INFO IS ANTICIPATED FOR THIS REPORT. LVAL bA FEMALE PT WAS ON THE WHOLE BODY TABLE HAVING A SPOT SCAN USING COLLIMATORS.THE TECHNOLOGIST (SGT. MARKLE) HAD TURNED AWAY FROM THE CAMERA WHEN HE HEARD A LOUD 'BANG' NOISE. HE LOOKED AT THE CAMERA A NOTED HEAD #2 HAD MOVED APPROX ONE (1) INCH DOWNW ARD TOWARD THE PT. THE TECHNOLOGIST TRANSLATED THE GANTRY TO THE HOME POSITION. THE PT GOT UP AND WALKED TO ANOTHER SCAN ROOM TO FINISH THE SCAN. THE TECHNOLOGIST CALLED CO TECH SUPPORT ENGINEER WAS IN THE HOSP FOR OTHER REASONS AND HE WAS ABLE TO BE IN THE SCAN ROOM IN A MATTEROF MINS. HE NOTED THE RADIUS SLIDE COVER HAD COME LOOSE. ENGINEER PULLED ON THE COVER AND LET IT SPRING BACK MAKING A LOUD 'BANG' NOISE THAT THE TECHNOLOGIST SAID WAS THE SAME NOISE HE HEARD. ENGINEER TOUCHED THE SENSE PA DAND HEARD THE RELAYS CLICK IN, RADIUS MOTOR MADE NOISE, BUT NO MOVEMENT OCCURRED. ENGINEER PRESSED ON THE SENSE PAD FOR HEAD NUMBER TWO (2) AND NOTEDTHE MOTOR & GEAR BOX MADE NOISE OF MOVEMENT, THE RADIUS HEIGHT COUNTER CHANGED, BUT THE HEAD DID NOT MOVE UP. LOOKED INSIDE OPENING ABOVE HEAD AND VISUALLY NOTED THE COLLAR ON THE GEAR BOX MOVING. ENGINEER SLIPPED A BUSINESSCARD IN AND DETERMINED THE RADIUS BALL SCREW WAS BROKEN THROUGH AT THE GEAR BOX COLLAR. THE FAILED BALL SCREW FRACTURED IN THE SHAFT SHANK AT THE BASE OF THE FILLET RADIUS OF THE SHANK/THREAD INTERFACE. THE FRACTURE WAS DUE TO ROTATING BENDING FATIQUE WITH A SEVERE STRESS CONCENTRATION AT THE FAILURE POINT BUT ONLY A SMALL NOMINAL STRESS. THE INTERFACE BETWEEN THE SHANK AND THE THREADS HAD A SHARP CORNER. THE BALL SCREW FRACTURED BY FATIGUE ON THE SHAFT SHANK AT THE BASE OF THE FILLET RADIUS OF THE SHANK/THREAD INTERFACE. SEVERAL DESIGN CHANGES WOULD INCREASE THE FATIGUE LIFE OF THE BALL SCREW: THE BALL SCREW SHOULD HA VE AS LARGE A FILLET AS POSSIBLE. THE RADIUS SHOULD BE SHOT PEENED. THE MICROSTRUCTURE OF THE SHAFT SHOULD CONSIST OF TEMPERED MARTENSITE, ESPECIALLY IN THE FAILED ZONE. IF THE HARDENED, THEN THE HARDENEDAND TEMPERED SURFACE ZONE SHOULD BE EXTENDED T O INCLUDE A SECTION OF TLVALAMBULANCE PERSONNEL ATTENDED TO A LARGE PT WITH A LONG HISTORY OF HEART PROBLEMS. THE PT WAS DIAGNOSED TO BE IN VENTRICULAR FIBRILLATION AND ONE ATTEMPT WAS MADE TO DEFIBRILLATE AT 200 JOULES. THE PT WAS NOT CONVERTED. REPORTEDLY EXTERNAL PACING WAS INITIATED AND CAPTURE WAS ACHIEVED WITH THE PACING ELECTRODES PLACED IN THE ANTERIOR/POSTERIOR POSITION. DURING TRANSPORT TO THE HOSP, PACING WAS INTERRUPTED AND THE LEADS OFF ALARM SOUNDED. AN ATTEMPT WAS MADE TO REINITIATE PACING HOWEVER THE UNIT C ONTINUED TO DISPLAY THE LEADS OFF ALARM. NO FURTHER ATTEMPTS WERE MADE TO RESUSCITATE DUE TO THE PTS LACK OF VIABILITY. THE OPERATOR LATER INDICATED HE DID NOT VERIFY PROPER CONNECTION BETWEEN THE PACING CABLE AND THE POSTERIOR PACING ELECTRODE. CO E VALUATED THE UNIT AND PROPER OPERATION WAS OBSERVED DURING PERFORMANCE AND FUNCTIONAL TESTING. THE UNIT WAS RETURNED TO THE CUSTOMER. COLONOSCOPY WAS PERFORMED ON A PT WHO SUBSEQUENTLY HAD TO BE READMITTED TO THE HOSP DUE TO A COMPLAINT OF ABDOMINAL PAIN. X-RAYS REVEALED A SMALL TEAR IN THE COLON AND ALTHOUGH SURGERY WAS NOT REQUIRED TO REPAIR THE TEAR, THE PT RECEIVED TREATMENT TO CORRECT THE PROBLEM. THE PT HAD BEEN ADMITTED TO THE HOSP WITH A PRE-EXISTING CONDITION OF DIVERTICULITIS. CO WILL NOT PERFORM AN EVALUATION OF THE ENDOSCOPE SINCE HOSP PERSONNEL PERFORMED A VISUAL AND MANUAL INSPECTION AND CONCLUDED THAT THERE WERE NO PROBLEMS WITH THE SCOPE. THE ENDOSCOPE HAS BEEN RETURNED TO SERVICE. PERFORATION OF THE COLON OCCURRED DURING COLONOSCOPY. THE PT HAD A PRE-EXISTING CONDITION OF COLITIS AND RECTAL BLEEDING AND AFTER THE PERFORATION WAS REPAIRED, THE PT WAS REPORTED TO BE IN STABLE CONDITION. CO WILL NOT PERFORM AN EVALUATION OF THE E NDOSCOPE SINCE HOSP PERSONNEL PERFORMED A VISUAL AND MANUAL INSPECTIHE SHANK. THE MORE OF THESE CHANGES THAT CAN BE INC, THE GREATER WILL BE THE IMPROVEMENT IN FATIGUE LIFE.|LVALfv j.DURING THE LAST THREE INCIDENT CALLS, THE DEVICE DISPLAYED CONTINUOUS "CHECK ELECTRODES" PROMPTS. THE PTS WERE NOT DIAPHORETIC. THE CUSTOMER ALSO STATED THAT THE PADS WERE SECURELY ADHERED TO PTS. PT OUTCOMES ARE UNKNOWN. THE FLUSH DEVICE CONTINUES TO FAST FLUSH AFTER IT SHOULD NOT. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE REPORTER STATED THAT THIS HAD OCCURRED ON MULTIPLE OCCASIONS BUT DID NOT PROVIDE DETAILS ON OTHER EVENTS. CAUTERY PENCIL WORKED INTERMITTENTLY. CAUTERY PENCIL WORKED INTERMITTENTLY. A WATER INLET SOLENOID HAD FAILED TOSHUT OFF COMPLETELY, ALLOWING WATER TO PASS THROUGH INTO THE BICARBONATE MIX TANK UNEXPECTEDLY ON 2 OCCASIONS. THE FIRST OCCASION WAS UNREPORTED UNTIL THE TIME OF THIS REPORT. ON THE SECOND OCCASION, THE WATER LEAK ED INTO THE MIX TANK DURING A TREATMENT SESSION. THIS LEAKAGE CAUSED A DILUTION OF THE BIRCARB SOLUTION, WHICH, WHEN DELIVERED TO THE DIALYSIS MACHINES, CAUSED THEM TO GO INTO "ALARM MODE" FROM A LOW CONDUCTIVEITY OR LOW PH READING. THOUGH THERE WAS NO INJURY, PTS' TREATMENT WAS DELAYED OR ENDED EARLY WHILE A NEW BATCH OF BICARBONATE SOLUTION WAS MIXED. A RECURRENCE OF THIS MALFUNCTION IS UNLIKELY TO CUASE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, UNLESS A DIALYIS SMACHINE WERE TO EXPERIENCE M ULTIPLE SIMULTANEOUS FAILURES. THE USER FACILITY WAS ADVISED TO REPLACE THE SOLENOID. TEH MACHINE WAS OUT OF WARRANTY, AND THE FAILURE OF THIS SOLENOID CAN BE EXPECTED, WITH PROLONGED USE. THE FACILITY IS RESPONSIBLE FOR MAINTENANCE OF THE MACHINERY, AND SHOULD HAVE REPLACED THE SOLENOID AT THE FIRST INDICATION OF MALFUNCTION DURING AN OPHTHALMIC PROCEDURE, PARTICULATE CAME FROM THIS HANDPIECE ONTO THE SURFACE ON THE PT'S EYE. THE PARTICULATE WAS WASHED FROM THE EYE. NO PT INJURY. PARTICULATE MAY HAVE COME FROM THIS HANDPIECE DURING A PHACOEMULSIFICATION PROCEDURE. NO PT INJURY. CLVALSTHE PLASTIC COLLAR AT THE JUNCTION WHERE THE PUMP CONNECTS TO THE ADURING AN OPHTHALMIC PROCEDURE, THE BIPOLAR MODE OF THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD NOT FUNCTION. ANOTHER BIPOLAR SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. ENGINEERING HAS IDENTIFIED THAT A HEX NUT INSTALLED IN THE DEVICE HAD COME LOOSE AND WAS RATTLING AROUND WITHIN THE DEVICE CASE. ALTHOUGH NO FAILURE RESULTED, THE METAL NUT COULD CAUSE AN ELECTRICAL SHORT,DISABLING THE DEVICE. PRODUCTION CONTROLS WIL L BE IMPLEMENTED TO HELP PREVENT A RECURRENCE OF THE NUT BECOMING LOOSE. CO IS CURRENTLY INVESTIGATING THE REPORTED MALFUNCTION. THE HOSP STAFF ATTEMPTED TO ADMINISTER EXTERNAL PACING TO A PT (DIAGNOSIS AND CONDITION NOT REPORTED) DURING A CODE. WHEN AN ATTEMPT WAS MADE TO START THE PACEMAKER, THE UNIT ALLEGEDLY DISPLAYED A 'PACING LEADS OFF' MESSAGE AND PACING WAS INHIBITED. A BACKUP PACEMAKER AND PACING CABLE WERE IMMEDIATELY AVAILABLE AND USED WITH NO OTHER PROBLEMS REPORTED. THE PT WAS NOT RESUSCIATED. THE REPORTER INDICATED THAT THE ALLEDGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THIS OPINION WAS BASED ON AN ASSESSMENT OF THE PT'S LACK OF VIABILITY. THE REPORTER SAID THAT PACING WOULDNOT HAVE MADE A DIFFERENCE IN THE PT'S OUTCOME. THE REPORTER EVALUATED THE PACING CABLE AND ALLEGEDLY OBSERVED ONE OF THE ELECTRODE CONNECTOR CONTACTS TO BE DIST ORTED/DAMAGED IN SUCH A WAY THAT IT WAS NOT MAKING ADEQUATE CONTACT WITH THE PACING ELECTRODE. THE REPORTER INDICATED THE CABLE HAD BEEN IN USE FOR APPROX 6 MONTHS TO 1 YEAR. THE REPORTER BENT THE CABLE CONNECTOR CONTACTS TO MAKE A SECURE CONNECTION WITH THE ELECTRODE CONTACTS AND OBSERVED PROPER OPERATION. THE REPORTER HAS ALSO ORDERED A REPLACEMENT PACING CABLE. RECOMMENDATIONS FOR ROUTINE TESTING OF THE PACING CABLE WERE REVIEWED WITH THE REPORTER. THE REPORTER EXPRESSED CONCERN ABOUT THE DES IGN OF THE CABLE CONNECTOR. IT WAS THE REPORTER'S OPINION THAT THE CONNECTOR SHOULD HAVE SOME TYPE OF POSITIVE LATCHING MECHANISM. LVAL~EMERGENCY MEDICAL TECH RESPONDED TO THE SCENE OF A WITNESSED CARDIAC ARREST. THE DEVICE WAS CONNECTED TO THE PT THROUGH THE DEFIBRILLATION CABLE AND ANALYSIS INITIATED. THE DEVICE DELIVERED 4 CONSECUTIVE COUNTERSHOCKS TO THE PT. THE PT WAS RESUSCITAT ED. THE REPORTER INDICATED THAT DEVICE OPERATION DID NOT AFFECT PT OUTCOME, BASED UPON A LACK OF PT VIABILITY. THE EVENT WAS REVIEWED BY THE REPORTER SUBSEQUENT TO COMPLETION OF THE RUN. THE REPORTER ALLEGES THAT THE DEVICE CRITICAL EVENT RECORD DOCU MENTED THE PT TO BE IN A NON SHOCKABLE RHYTHM AT THE TIME THE DEVICE ANALYZED AND DELIVERED THE FOURTH COUNTERSHOCK. THE REP OBSERVED PROPER DEVICE OPERATION, THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FO R USE. A FACTORY EVAL OF THE DEVICE CODE CRITICAL EVENT RECORD DETERMINED THE DEVICE OPERATED PROPERLY AT THE TIME OF THE REPORTED EVENT. FIRE DEPT PARAMEDICS USED THE UNIT IN AN ATTEMPT TO ADMINISTER EXTERNAL PACING TO A PERSON DIAGNOSED IN FULL CARDIAC ARREST. THE PT WAS A DIALYSIS PT. THE OPERATOR ATTEMPTED TO CONNECT THE PACING CABLE CONNECTORS TO THE PACING ELECTRODES AND THE CONN ECTORS ALLEGEDLY WOULD NOT FIT THE CONNECTOR POSTS ON THE ELECTRODES. ATTEMPTS AT PACING WERE DISCONTINUED. THE PT WAS NOT RESUSCITATED. THE REPORTER SAID THAT THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PTS DEATH. ATTEMPTS AT PACING W ERE DESCRIBED AS A "LAST DITCH EFFORT". THE PTS FAMILY ARRIVED LATER WITH 'DO NOT RESUSCITATE' PAPERWORK. THE REPORTER INVESTIGATED THE REPORTED EVENT AND FOUND THE ROOT CAUSE TO BE OPERATOR ERROR. THE OPERATOR USED A PACING CABLE MODIFIED FOR USE WI TH PACING ELECTRODES. THE ELECTRODE CONNECTORS ARE NOT COMPATIBLE WITH PACING ELECTRODES. THE CORRECT PACING CABLE WAS OBTAINED BY THE USER. TLVALa7dTHE PLASTIC COLLAR AT THE JUNCTION WHERE THE PUMP CONNECTS TTHE DEVICE LEAKED BETWEEN THE TUBING AND THE DRIP CHAMBER DURING CHEMOTHERAPY INFUSION. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER RETURNED TWO STERILE SAMPLES TO CO FOR EVALUATION. EXAMINATION OF THE RETURNED UNITS REVEALED THAT NONE LEAKED AND ALL PASSED THE PULL TEST. CO WAS UNABLE TO CONFIRM THIS COMPLAINT OR DETERMINE THE CAUSE. BASED UPON THE ABOVE INFO, CO HAS DETERMINED THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. DURING QUALIFICATION DROP TESTING BY CO BOSSES WERE SHEARED OFF IN THE UPPER AND LOWER CASES. IN SOME CASES A HOLE WAS OPENED TO THE OUTSIDE OF THE MONITOR. A FUNCTIONAL FAILURE COULD RESULT IF WATER/FLUID ENTERS AN OPENING IN THE CASE. CO IS CURRENT LY INVESTIGATING THE REPORTED MALFUNCTION. A BASIC LIFE SUPPORT(BLS)TEAM WAS ON SCENE OF A PT, DESCRIBED WITH AN UNSTABLE, BUT NORMAL, SINUS RHYTHM. PARAMEDICS ARRIVED ON SCENE AND CONNECTED THE PT TO THE CO'S MONITOR. THE DEVICE DISPLAYED THE PT RHYTHM AS A FLATLINE TRACE. ANOTHER PT CABLE W AS USED, IN AN UNSUCCESSFUL ATTEMPT AT CORRECTION. PARAMEDICS DISCONTINUED USE OF THE MONITOR AND USED A SEMI-AUTOMATED EXTERNAL DEFIBRILLATOR, OWNED BY THE BLS TEAM, TO CONTINUE PT MONITORING. THE FACILITY PARAMEDIC SUPERVISOR TESTED THE MONITOR SUB SEQUENT TO THE EVENT AND REPORTEDLY OBSERVED THE DEVICE WOULD INAPPROPRIATELY DISPLAY A FLATLINE TRACE. THIS WAS ALLEGED TO OCCUR WHEN MECHANICAL STRESS WAS APPLIED ON A ECG CABLE WHERE IT MATES TO THE DEVICE ECG CONNECTOR. THE DEVICE HAD INITIALLY B EEN TESTED BY THE REP OBSERVED PROPER DEVICE OPERATION AT THAT TIME. NO ECG CABLE WAS RETAINED BY THE FACILITY FOR EVAL BY THE SVC REP. THE DEVICE HAD REMAINED IN A HOLDING AREA OUT OF USE. SUBSEQUENT TO THE ALERT DATE OF 12/12/95, THE REP RE-EXAMINE D THE DEVICE, SPECIFIC TO THE CLAIM OF FLATLINE WITH FLEXURE AT THE ECG CONNECTOR. AGAIN, PROPER DEVICE OPERATIONWAS OBSERVED. THE DEVICE WILL BE RETURNED TO USE AT THIS TIME. LVAL}G;A TEAR WAS FOUND IN THE BLUE DISTAL (BRONCHIAL) CUFF. THE DEVICE WAS RETURNED. THE DEVICE SHOWS SIGNS OF BEING USEDDURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSSURGICAL SYSTEM WOULD NOT CAPTURE THE FLUID COLLECTION CASSETTE. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED INTERMITTENT POWER. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIEECE EXHIBITED INTERMITTENT POWER AND INTERFERED WITH THE OPERATION OF THE OPHTHALMIC MICROSURGICAL SYS BEING USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE. THERE WAS N O PT INJURY. DURING AN OPHTHALMIC PROCEDURE, THIS BIPOLAR COAGULATOR WOULD NOT FUNCTION. ANOTHER BIPOLAR COAGULATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. PHACOEMULSIFICATION HANDPIECE FAILED DURING A CATARACT EXTRACTION PROCEDURE. THERE WAS NO REPORT OF PT INJURY. NO ADD'L INFO IS AVAILABLE. PT WENT IN FOR REMOVAL OF IMPACTED 3RD MOLAR NUMBER 13. AS DR WAS CUTTING GUM (GOING AROUND NR 15) HE HEARD A CRACKING SOUND AND THE TIP OF THE BLADE IMMEDIATELY DISAPPEARED. THE PHYSICIAN HAD PLACED A "DRAPE" IN BACK OF MOUTH TO PREVENT FOREIGN OBJE CTS GOING DOWN THROAT BUT IT DID NOT WORK IN THIS CASE. HE IMMEDIATELY CHECKED THE THROAT, USING A LARYNGEALSCOPE CHECKED THE ESOPHAGUS, THEN WITH FINGERS CHECKED SOFT PLATE AND UPPER NASAL PASSAGE. NO TIP OF BLADE FOUND. HE FINISHED PROCEDURE AND AD VISED PT'S MOTHER TO TAKE HER TO A HOSP FOR FURTHER OBSERVATION PLUS TREATMENT. PT LEFT FOR ER, A 15 MIN DRIVE, X-RAY TAKEN A PIECE OF BLADE SEEN IN PTS STOMACH. PT WAS TRANSFERRED TO ENDOSCOPIC CLINIC WHERE DR WITH A GASTRO-ENDOSCOPE REMOVED THE TIP OF THE BLADE FROM PT'S STOMACH. NO DAMAGE TO ESOPHAGUS OR STOMACH FOUND. UPON POST-OP CHECK UP EVERYTHING WITH PT IS FINE NO SIGN OF INJURY. !wlS_]giIING THIS SYSTEM DURING A CATARACT 856671960110NUCLEAR MEDICINE DIAGNOSTIC IMAGING SYSTEMSTRIORESELABOTRIONIX RESEARCH LABORATORY, INC.MALFUNCTIONBIAD2400RADIOLOGYIYXFYaxtpeD8   856662960110SPIRAL-FLEX TRACHEAL TUBESKENDSHERKENDALL SHERIDANMALFUNCTION5-12615ANESTHESIOLOGYBTRF@`ocb_QJJ?/'   856661960110SPIRAL-FLEX TRACHEAL TUBEKENDSHERKENDALL SHERIDANMALFUNCTION5-12614, 5-12615ANESTHESIOLOGYBTRF_wkjgYII>.&   856660960110SHER-I-BRONCH LEFTKENDSHERKENDALL SHERIDANMALFUNCTION5-16037ANESTHESIOLOGYBTSF@^g[ZWIBB7'   856659960110SHER-I-BRONCH LEFTKENDSHERKENDALL SHERIDANMALFUNCTION5-16039ANESTHESIOLOGYBTSF@]g[ZWIBB7'   856658960110SPIRAL-FLEX TRACHEAL TUBESKENDSHERKENDALL SHERIDANMALFUNCTION5-12910ANESTHESIOLOGYBTRFC@]ocb_QJJ?/'   856637960116COLOVIDEOSCOPEOLYMPUSOLYMPUS AMERICA, INC.MALFUNCTIONCF-100L10031GASTRO & UROLOGYFDFF@Xnba^NIB7"   856635960102XENON LIGHT SOURCEOLYMPUSOLYMPUS AMERICA, INC.MALFUNCTIONCLV-U208101131GASTRO & UROLOGYFFSF@]thgdTMF;&   856630960104PERCUPUMP CEILING MOUNT SYSTEMEZEME-Z-EM, INC.MALFUNCTIONNA5885CARDIOVASCULARIZQF\j^]ZLHF;/+   856629960104PERCUPUMP CEILING MOUNT SYSTEMEZEME-Z-EM, INC.MALFUNCTIONNA5885CARDIOVASCULARIZQF1Zj^]ZLHF;/+   856599960105LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKERPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION10804200-28CARDIOVASCULARLDDFz@Yxwtf][P<4   856598960116VIDEO COLONOSCOPEOLYMPUSOLYMPUS AMERICA, INC.SERIOUS INJURYCF-100TL10037GASTRO & UROLOGYFDFPC@YuiheUPH:%   856597960116COLONOSOLYMPUSOLYMPUS AMERICA, INC.SERIOUS INJURYCF-100L10031GASTRO & UROLOGYFDFP@Yj^]ZJE>0   8565489601054F OMNI SELECTIVE CATHETERANGIODYNAMICSANGIODYNAMICS DIV. 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PENCILCONMEDCONMED CORP.MALFUNCTIONNA130305GEN & PLASTIC SURGERYGEIFDIDN'T WORK. |_^[F@>3'!   856843960102BIRTCHER E.S. 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  857368960112STAINLESS STEEL MICROSEAL PHACOEMULSIFICATION HANDSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP8040OPHTHALMICHQCF@v|{xnhf[G?   857367960112STORZ PROTEGE ANTERIOR SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADPX100OPHTHALMICHQEF@vsgfcYSQF2*   857366960112STAINLESS STEEL MICROSEAL PHACOEMULSIFICATION HANDSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP8040OPHTHALMICHQCF@u|{xnhf[G?   857365960112STAINLESS STEEL MICROSEAL PHACOEMULSIFICATION HANDSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP8040OPHTHALMICHQCF@u|{xnhf[G?   857364960112STORZ PREMIERE MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNAP32212OPHTHALMICHQEF@symli_YWL80   857360960111STORZ PREMIERE MICROCURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNAP31112OPHTHALMICHQCF@vymli_YWL80   857359960111STORZ PREMIERE MICROSURGICAL SYSTEMSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP2062OPHTHALMICHQEF@ rwkjg]WWL80   857358960111STORZ PREMIERE STAINLESS STEEL PHACOEMULSIFICATIONSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONDP8020OPHTHALMICHQEF@rzyvlff[G? 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MALLINCKRODTMALFUNCTIONNA118-75ANESTHESIOLOGYBTRF(@w~{mgeZ-%   857371960112STAINLESS STEEL MICROSEAL PHACOEMULSIFICATION HANDSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP8040OPHTHALMICHQCF@w|{xnhf[G?   857370960112STAINLESS STEEL MICROSEAL PHACOEMULSIFICATION HANDSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP8040OPHTHALMICHQCF@w|{xnhf[G?   eST?KU_HTHE PLASTIC COLLAR AT THE JUNCTI 857770960115SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN & PLASTIC SURGERYFWMFh@|rfebMF?4   857749960118FIRST MEDIC SEMI-AUTOMATIC DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION61090526-01CARDIOVASCULARMKJF0@{yxug_\Q=5   857748960118LIFEPAK DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION8802700CARDIOVASCULARLDDF@{nba^PJI>*"   857747960118FIRST MEDICPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION51090510-01CARDIOVASCULARMKJF;@{h\[XJB?4    857746960117VOLUMETRIC INFUSION PUMP SETMEDEXMEDEX, INC.MALFUNCTIONNAIV3D12-IV3GEN HOSPITALFPAFb@{l`_\PFD9.)   857745960117T CONNECTOR WITH MALE LUER SLIPMEDEXMEDEX, INC.MALFUNCTIONNAMX453GEN HOSPITALFPAF@{j^]ZNIG<1,   857744960117VOLUMETRIC INFUSION PUMP SETMEDEXMEDEX, INC.MALFUNCTIONNAIV3A03GEN HOSPITALFPAFw@{h\[XLFD9.)   857743960116NEONATE MONITORING/SAMPLE LINEMEDEXMEDEX, INC.MALFUNCTIONNAMX8033CARDIOVASCULARDRSF @zl`_\NHF;0+   857732960116LIFEPAK AUTOMATIC ADVISORY DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION300804900-03CARDIOVASCULARMKJF@zzyvh_\Q=5   857730960118LIFEPAK DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION6S801585CARDIOVASCULARLDDF@zocb_QKI>*"   857558960112INFRARED IIGRAHFIELGRAHAM-FIELD INC.SERIOUS INJURY05-HT510-51505-HT510-515PHYS MEDILYF @yocb_WK?1    857544960103INFRARED HEXGRAHFIELGRAHAM-FIELD INC.SERIOUS INJURY05-HT510-51505-HT510-515PHYS MEDILYF@ypdc`XL@2!   857542960112HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.MALFUNCTIONHS 3000920061CARDIOVASCULARMKJF@yj^]ZLF?4   857397960115STORZ PREMIERE STAINLESS STEEL PHACOEMULSIFICATIONSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP8020OPHTHALMICHQCF@y|{xnhf[G?   857392960115ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONNAEZ35BGEN & PLASTIC SURGERYGAGF@y~{fa_T:.  LVAL7lr&,WHILE THE CONTACT WAS TIGHTENING THE FOOT PEDAL CONNECTOR TO THIS OPHTHALMIC A-SCAN, SHE RECEIVED A SHOCK. THERE WAS NO INJURY. ON 12/19/95 AT END OF PROCEDURE FOR A THERAPEUTIC ABORTION, PHYSICIAN USED THE CURRETTE TO SCRAPE THE WALLS OF THE UTERUS. THE TIP OF THE CURETTE BROKE OFF IN THE PT. PHYSICIAN ATTEMPTED TO REMOVE THE PIECE BY EVACUATION. ULTRASOUND DETECTED THE PIEC E REMAINED IN THE PT. SECOND PROCEDURE TO REMOVE TIP OF CURETTE SUCCESSFULLY DONE ON 1/2/96. PT HAS NOT SUSTAINED INJURY. ALL OTHER CONDITIONS ARE NORMAL. REPORTER INDICATED THAT THE CURETTE USED WAS APPROX 20 YRS OLD. FEMALE PT'S AGE >18, WT: 130. O N 2/3/96 ADVISED REPORTED TO EXAMINE INSTRUMENTS PRIOR TO USE, AND TO INSTITUTE A PROGRAM TO INSPECT ALL SURGICAL EQUIPMENT ON A ROUTINE BASIS. WHEELS FELL OFF FOUR OF CUSTOMER COTS. ADD'L SERIAL NUMBERS: L-296181, L-293319. ADD'L LOT NUMBER: M189990. THE COT FOLDED TO THE GROUND. ADD'L SERIAL NUMBERS: L-340214, L-340220. SIGNAL SLOWLY DRIFTS DOWN ON SCREEN AND DISAPPEARS AT BOTTOM. STRIP DUPLICATES SCREEN. NO PT COMPROMISE. OBSERVATION: UNABLE TO VERIFY CUSTOMER COMPLAINT. MONITOR RAN FOR OVER 6 HOURS WITHOUT INCIDENT. ECG SIGNAL ON SCREEN AND PRINTER IS STABLE. THE FEMALE LUER OF THE STOPCOCK BECAME DISCONNECTED FROM ANOTHER MFR'S DEVICE DURING BLOOD INFUSION. NO PT INJURY OR TREATMENT. THE STOP COCK BROKE IN HALF DURING USE. NO PT INJURY OR TREATMENT. AFTER THE PT HAD BEEN PREPPED FOR A VITRECTOMY PROCEDURE AND THE INITIAL INCISION HAD BEEN MADE, THE VITRECTOMY MODE OF THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD NOT FUNCTION CORRECTLY AND COULD NOT BE USED. THIS CUSTOMER DOES NOT NORMALLY TEST THE SYSTEM BEFORE THE START OF A PROCEDURE. THE PHYSICIAN THEN PERFORMED RETINOPEXY WHERE A GAS BUBBLE IS PLACED IN THE EYE TO HOLD THE RETINA IN PLACE. THE PT IS DOING WELL AND NO ADD'L SURGERY IS PLANNED. 2LVAL xDs*NAN ANESTHESIOLOGIST INTUBATED A PT WITH ONE THE DEVICE WAS USED DURING A WEDGE RESECTION. THE DISTAL STAPLES DID NOT FORM PROPERLY, WHICH RESULTED IN BLEEDING. HEMOSTASIS WAS ACHIEVED WITH SUTURES AND A COMPETITOR'S DEVICE. THERE WAS NO CONSEQUENCE TO THE PT. INTERNAL LAYER OF MATTRESS SEPARATED CAUSING BUBBLE TO FORM IN THE MATTRESS SURFACE. TEST CONFIRMS CELL SEPARATION. DURING TESTING PROCEDURE THE FEEDING PUBP OVER-DELIVERED. THE FEEDING PUMP WAS TESTED FOR AN HOUR USING SALINE SOLUTION. THE PUMP WAS SET TO DELIVER 50ML/HR. BUT DELIVERED 60ML IN AN HOUR. NO PT USE OR INJURY WAS INDICATED. DURING TESTING PROCEDURE THE FEEDING PUMP OVER-DELIVERED. THE FEEDING PUMP WAS TESTED FOR AN HOUR USING SALINE SOLUTION. THE PUMP WAS SET TO DELIVER 50 ML/HR. BUT DELIVERED 60ML IN AN HOUR. NO PT USE OR INJURY WAS INDICATED. LUER LOCK CONNECTOR AND CATHETER SEPARATED AT A FLOW RATE OF 24 ML/DAY. SOME BLOOD LOSS RESULTED. BLOOD COLLECTION DEVICE WAS INSERTED INTO IV LINE AND IT BROKE AT THE HUB. CANNULA WAS REMOVED INTACT. THE INSERT FRACTURED WHILE IN THE PT'S MOUTH. THERE WAS NO INJURY. DURING A PHACOFRAGMENETATION PROCEDURE, THIS OPHTHALMIC NEEDLE CRACKED IN HALF. ANOTHER NEEDLE AND FRAGMENTATION HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY; HOWEVER, THE PROCEDURE WAS DELAYED APPROX ONE HR. DURING A CATARACT EXTRACTION PROCEDURE USING THIS OPHTHALMIC MICROSURGICAL SYSTEM, INTRAOCULAR PRESSURE WAS TOO HIGH. THE SYSTEM WAS EXCHANGED AND THE CONTENTS OF THE BALANCED SALT SOLUTION BOTTLE WAS DECREASED. THE PROCEDURE CONTINUED WITH NO PT INJ URY; HOWEVER, THE PT'S BLOOD PRESSURE TEMPORARILY INCREASED TO A VERY HIGH LEVEL. THE CAUSE FOR THE BLOOD PRESSURE INCREASE IS NOT KNOWN. IF ADD'L INFO IS RECEIVED FROM THE CONTACT CONCERNING THE BLOOD PRESSURE INCREASE, IT WILL BE REPORTED AS FOLLOW -UP TO THIS REPORT. THE SYSTEM WAS EVALUATED AND, ALTHOUGH NO PROBLEM COULD BE FOUND, THE ASPIRATION FUNCTION OF THE SYSTEM WAS RECALIBRATED. oLVAL y= S ON THE WHOLE BODY TABLE HAVING A SPOT SCAN USING COLLIMATORS.THE TECHNOLOGIST (SGT. MARKLE) HAD TURNED AWAY FDURING AN OPHTHALMIC PROCEDURE, THE FOOTPEDAL FOR THIS OPHTHALMIC MICROSURGICAL SYSTEM WOULD NOT ALLOW FOR PROPER CONTROL OF FLUID INTO THE EYE. THE PROCEDURE WAS DELAYED UNTIL ANOTHER SYSTEM COULD BE SET UP AND USED. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE COULD NOT BE USED. THERE WAS NO REPORT OF PT INJURY. TWO OF THESE VITRECTOMY CUTTERS WERE RETURNED WITH INFO THAT CUTTERS CAME APART DURING A VITRECTOMY PROCEDURE. THERE WAS NO REPORT OF INJURY. NO ADD'L INFO IS AVAILABLE. DURING TESTING, DISCOVERED ON/OFF BUTTON WORKS INTERMITTENTLY. ONCE ON, UNIT WORKS PROPERLY. OBSERVATION: FOUND UNIT HAD BEEN OPENED AND TAMPERED WITH. COLD SOLDER JOINT ON RESISTOR R4 ON ANALOG BOARD RESOLDERED. UNIT FUNCTIONS PROPERLY. CAUTERY PENCIL REMAINED IN THE "ON" POSITION. CAUTERY PENCIL REMAINED IN THE "ON" POSITION. CAUTERY PENCIL REMAINED IN THE "ON" POSITION. HOSP REPORTED ONLY THAT "IT WAS FOUND TO BE DEFECTIVE." THE DEVICE WAS USED DURING A SPLENECTOMY. THE DEVICE STOPPED FUNCTIONING AND BROKE BEFORE THE STAPLELINE WAS FORMED. A SECOND DEVICE WAS INTRODUCED WITH THE SAME RESULTS. A THIRD DEVICE WAS INTRODUCED, WHICH BROKE DURING FIRING CYCLE, RESULTING IN SE RIOUS BLEEDING FROM THE SPLENIC ARTERY. THERE WAS NO CONSEQUENCE TO THE PT. THE DEVICE CHARGED IN A RESUSCITATION ATTEMPT. THE PADDLE CHARGE LED CONTINUED TO FLASH, INDICATING THAT CHARGE WAS NOT COMPLETE. THE OPERATOR ALLEGEDLY INSTALLED A TOTAL OF FOUR DEVICE BATTERIES IN AN UNSUCCESSFUL ATTEMPT AT CORRECTION. ANOTHER PARA MDIC TEAM ARRIVED ON SCENE AND USED THEIR MANUAL DEFIBRILLATOR TO ADMINISTER A 200 JOULE COUNTERSHOCK TO THE PT. THE PT WAS NOT RESUSCITATED. THE REPORTER INDICATED THE PT OUTCOME WAS NOT THE RESULT OF DEVICE OPERATION, BASED UPON AN ASESSMENT OF PT CONDITION. CO IS CURRENTLY INVESTIGATING THE REPORTED MALFUNCTION. LVALTHE DEVICE LEAKED BETWEEN THE TUBING AND THE DRIP CDURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL SYSTEM EXHIBITED EXCESSIVE ASPIRATION. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE SYSTEM WAS EVALUATED AND NO PROBLEM COULD BE FOUND. DURING AN INCIDENT CALL INVOLVING A 64 YEAR OLD MALE PT IN CARDIAC ARREST, THE DEVICE DELIVERED FOUR SHOCKS TO THE PT. THE OPERATORS ALLEGED THAT THERE WAS NO VISIBLE PT MOVEMENT WHEN THE SHOCKS WERE DELIVERED. AN ALS TEAM THEN ARRIVED, ASSUMED PT CA RE, AND PRONOUNCED THE PT ON SCENE. THE CUSTOMER STATED THAT DEVICE FUNCTION DID NOT AFFECT PT OUTCOME. DURING A MONITORING CALL, THE DEVICE REPORTEDLY DISPLAYED AN ASYSTOLIC RHYTHM AFTER A "CHECK ELECTRODES" PROMPT WAS CLEARED. DURING TESTING BY THE CUSTOMER USING MONITORING PADS ON THEMSELVES AFTER THE INCIDENT, THE DEVICE REPORTEDLY AGAIN DISPLAYED AN ASYSTOLIC RHYTHM. THE RETURNED DEVICE WAS INVESTIGATED AND ANALYZED BY A SERVICE TECHNICIAN. A RELAY WAS FOUND TO HAVE MALFUNCTIONED WHICH MAY HAVE PREVENTED THE UNIT FROM OPERATING PROPERLY. THE CIRCUIT BOARD ON WHICH THE RELAY IS LOCATED WAS REP LACED. THE DEVICE WAS THEN VERIFIED TO OPERATE PROPERLY. IT WAS THOROUGHLY TESTED TO ALL DEVICE SPECIFICATIONS AND WAS FOUND TO BE FULLY COMPLIANT, OPERATING NORMALLY THROUGH ALL TESTS COMPLETED. THE BOARD WAS RETURNED TO THE MFR WHO ANALYZED THE BOA RD AND RETURNED THE RELAY TO THE VENDOR FOR EVALUATION. THE CIRCUIT BOARD WAS ANALYZED AND TESTED AND WAS FOUND TO MEET ALL TEST REQUIREMENTS. THE RELAY MALFUNCTION WAS CONFIRMED BY THE VENDOR. FINALLY CO SERVICE DEPT VERIFIED THE DEVICE'S CALIBRATIO N AND SUCCESSFULLY CONDUCTED A A FUNCTIONAL ARRHYTHMIA TEST WITHOUT OBSERVING ANY PERFORMANCE DEVIATIONS OR IRREGULATIES. THEREFORE, AS A RESULT OF CO'S INVESTIGATION AND SERVICE, CO BELIEVES THIS MALFUNCTION TO BE AN ISOLATED OCCURRENCE. THE CUSTOME R WILL BE INFORMED OF THESE FINDINGS. hLVAL!z&,THE TUBING SPLIT AND LEAKED FLUID AND BLOOD. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT RETURN SAMPLES FOR EVAL. RETAINED SAMPLES WERE EVALUATED AND THE LOT HISTORY WAS REVIEWED. ALL UNITS WERE ACCEPTABLE PER CO SPEC. CO WAS UNABLE TO CONFIRM THIS COMPLAINT OR DETERMINE THE CAUSE. BASED UPON THE ABOVE INFO, CO HAVE DETERMINED THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. THE MEMBRANE ON THE PUMP SET CAME OFF AND LEAKED CHEMOTHERAPY DRUGS DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THREE SAMPLES WERE RETURNED TO CO FOR EVAL. EXAMINATION OF THE RETURNED UNITS REVEALED THAT THE MEMBRANE O N ONE OF THE THREE UNITS WAS NOT ON. IT APPEARED THAT THE MEMBRANE HAD BEEN PRIMED UNSUPPORTED. THIS IS AN INSERVICING ISSUE. RETAINED SAMPLES WERE EVALUATED AND THE LOT HISTORY WAS REVIEWED. ALL UNITS WERE ACCEPTABLE PER CO SPEC. CO WAS ABLE TO CONF IRM THIS COMPLAINT. BASED UPON THE ABOVE INFO, CO HAS DETERMINED THAT THIS ISSUE WILL BE ADDRESSED WITH INSERVICING AND THAT NO ADD'L ACTION IS NECESSARY AT THIS TIME. THE SYSTEM WAS IN A DOWN RADIUS MOTION. WHEN TECHNOLOGIST RELEASED BUTTON, MOTION CONTINUED CAUSING CONTACT WITH PT. SAFETY PAD WAS IN PLACE BUT FAILED TO OPERATE. PT WAS EXAMINED BY PHYSICIAN, BRUISE TO RIGHT CHEEK WAS FOUND. FIELD SVC ENGINEER FOUN D A FAULTY HAND CONTROL AND SAFETY PAD. BOTH HAVE BEEN REPLACED. DEFIBRILLATION ELECTRODES WERE ATTACHED TO A PT DURING TRANSPORT TO THE HOSP. AFTER ARRIVAL AT THE HOSP A DECISION WAS MADE TO COUNTERSHOCK THE PT. THE OPERATOR OF THE DEFIBRILLATOR THOUGHT THE DEFIBRILLATION ELECTRODES WERE DEFIBRILLATION PADS, PLAC ED THE PADDLES ON TOP OF THE DEFIBRILLATION ELECTRODES & COUNTERSHOCKED THE PT. THE OPERATOR ALLEGED THAT ENERGY WAS NOT DELIVERED TO THE PT. THE DEFIBRILLATION ELECTRODES WERE REMOVED FROM THE PT & THE RESUSCITATION CONTINUED. THE PT WAS RESUSCITATE D. LVAL DLLAR AT THE JUNCTION WHERE THE PUMP CONNECTS TO THE ARTICULATING ARM CRACKED AND THE PUMP FELL OFF THE CEILING DURING AN OPHTHALMIC PROCEDURE, THE FOOTPEDAL FOR THIS OPHTHALMIC MICROSURGICAL DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED REDUCED POWER. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE FAILED TO CALIBRATE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WS NO PT INJURY. PARAMEDICS USED THE UNIT TO TREAT A PT IN CARDIAC ARREST. ALLEGEDLY THE CHARGE SWITCH WAS PRESSED SEVERAL TIMES BEFORE THE DEFIBRILLATOR CHARGED TO THE SELECTED ENERGY. THE PT WAS THEN COUNTERSHOCKED. ALLEGEDLY THE SAME THING OCCURRED THE SECOND TIME AN ATTEMPT WAS MADE TO CHARGE THE DEFIBRILLATOR. PERSONNEL AT THE EMS STATED THE PT OUTCOME WAS UNKNOWN. THE UNIT WAS EVALUATED BY CO. ELECTRICAL AND PERFORMANCE TESTING WAS DONE AND THE UNIT WAS MECHANICALLY INSPECTED. PROPER OPERATION WAS OBSERVED . THE BATTERIES USED DURING THE REPORTED INCIDENT WERE NOT RETURNED FOR EVAL. ALL BATTERIES AT THAT AMBULANCE STATION WERE REPLACED. BATTERY MAINTENANCE PROCEDURES WERE REVIEWED WITH PERSONNEL AT THE EMS. THE CASSETTE WAS CRACKED. THIS ISSUE WAS FOUND UPON PRIMING OF THE SET. THE SET WAS NOT IN USE ON THE PT AT THE TIME. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER RETURNED ONE SAMPLE FOR EVAL. EXAMINATION OF THE RETURN ED UNIT REVEALED THAT THE CASSETTE WAS CRACKED. IT IS UNCLEAR WHAT CAUSED THIS CRACK. IT IS POSSIBLE THAT IT WAS ASSOCIATED WITH THE INFUSATE IN CONJUNCTION WITH THE WAY IN WHICH IT WAS HANDLED. CO WILL CONTINUE TO INVESTIGATE THIS ISSUE. RETAINED SA MPLES WERE EVALUATED AND THE LOT HISTORY WAS REVIEWED. ALL UNITS WERE ACCEPTABLE PER CO SPEC. CO WAS ABLE TO CONFIRM THIS COMPLAINT. BASED UPON THE ABOVE INFO, CO HAS DETERMINED THAT THIS ISSUE IS BEING ADDRESSED, AND THE INVESTIGATION WILL CONTINUE. cLVAL0?&w"[@THE PLASTIC COLLAR AT THE JUNCTION WHERE THE PUMP CONNECTS TO THE ARTICULATING DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE HANDPIECE FAILED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, THE BIPOLAR FUNCTION OF THIS OPHTHALMIC MICROSURGICAL SYSTEM COULD NOT BE ACTIVATED. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT PERFORMING THE CAUTERY PHASE. THE SYSTEM WAS EVALUATED AND NO PROBLEM WAS FOUND . THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE USING THIS OPHTHALMIC MICROSURGICAL SYSTEM, ASPIRATION SEEMED TO BE LOW. ALTHOUGH THE COMPLAINT RECEIVED CONCERNED THE SYSTEM, THE PHACOEMULSIFICATION HANDPIECE USED WAS EXCHANGED FOR AN IRRIGATION/ASPIRATION HA NDPIECE AND THE PROCEDURE COMPLETED. THERE WAS NO PT INJURY. THE SYSTEM WAS EVALUATED AND NO PROBLEM COULD BE FOUND. NO HANDPIECE WAS RETURNED. DURING A CATARACT EXTRACTION PROCEDURE, THIS OPHTHALMIC MICROSURGICAL SYSTEM INTERMITTENTLY DISPLAYED FALSE "CASSETTE FULL" PROMPTS. THIS PROMPT SHUTS DOWN THE SYSTEM. ANESTHESIA HAD BEEN ADMINISTERED TO THE PT, HOWEVER, NO INCISION HAD BEEN MADE. TH E PROCEDURE WAS CANCELED AND RESCHEDULED.THERE WAS NO PT INJURY. THE SYSTEM WAS RETURNED FOR EVAL. EMS PERSONNEL USED THE UNIT TO PACE A PT IN SOME TYPE OF BRADYCARDIC ARRHYTHMIA. ALLEGEDLY WHEN PACING WAS INITIATED THE CRT DISPLAY WENT BLANK OR THE UNIT LOST POWER. FURTHER ATTEMPTS TO PACE THE PT WERE DISCONTINUED AT THAT TIME BECAUSE THE PT WAS TRANSFERRED TO HOSP PERSONNEL FOR TREATMENT. THE REPORTER DID NOT KNOW THE PT OUTCOME. AFTER THAT THE EMS PERSONNEL CYCLED POWER ON THE DEFIBRILLATOR/MONITOR/PACEMAKER AND THE UNIT THEN FUNCTIONED AS EXPECTED. CO EVALUATED THE UNIT BY DOING ELECTRICA L AND PERFORMANCE TESTING, AND MECHANICAL INSPECTION. THE REPORTED MALFUNCTION OF BLANK CRT DISPLAY OR UNIT SHUTDOWN WAS NOT CONCLUSIVELY DUPLICATED. THE MAIN PCB ASSEMBLY WAS REPLACED AND THE UNIT RETURNED TO USE. LVAL;, giI 856671960110NUCLEAR MEDICINE DIAGNOSTIC IMAGING SYSTEMSTRIORESELABOTRIONIX RESEARCH LABORATORYWHILE THE CONTACT WAS TIGHTENING THE FOOT PEDAL CONNECTOR TO THIS OPHTHALMIC A-SCAN, SHE RECEIVED A SHODURING A RIGHT HEMICOLECTOMY THE DEVICE "DID NOT FEEL EXACTLY RIGHT" UPON FIRING. POSTOPERATIVLEY, THE PT DEVELOPED AN ANASTOMATIC LEAK. NO INTERVENTION WAS REQUIRED, HOWEVER, SURGEON EXPRESSED CONCERN ABOUT THE EVENT. THERE WAS NO CONSEQUENCE TO THE PT. UPON OPENING THE PACKAGED DEVICE, THE TUBE WAS VISUALLY OBSERVED TO BE COLLAPSED. THE PRODUCT WAS NOT USED. THERE WAS NO REPORTED PT INJURY. THE REPORT DEVICE WAS EXAMINED BY THE MFR. THE TUBE EXHIBITED A LARGE COMPRESSED AREA. ALSO THE DEVICE WAS NO TED TO HAVE DEPOSITS OF LUBRICANT PRESENT ON THE CUFF AND IN THE INTERIOR OF THE TUBE. LUBRICANT WAS ALSO OBSERVED ON THE INSIDE OF THE PACKAGE WHERE THE DISTAL PORTION OF THE DEVICE HAD BEEN LOCATED. THE RETAIN SAMPLE FROM THE REPORTED LOT NUMBER WA S FOUND TO BE FREE FROM THE PHYSICAL DAMAGE PRESENT ON THE RETURNED REPORT DEVICE. CONCLUSION: CONFIRMED; THE DEVICE HAD BEEN SUBJECTED TO PHYSICAL DAMAGE. THE PRESENCE OF LUBRICANT ON THE DEVICE INDICATES THAT THE DEVICE HAD BEEN HANDLED AT SOME POI NT AFTER DISTRIBUTION FROM THE MANUFACTURING SITE. DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED REDUCED POWER. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE EXHIBITED REDUCED POWER. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, ONE OF THESE PHACOEMULSIFCATION HANDPIECES WOULD NOT FUNCTION EVEN THOUGH IT CALIBRATED PRIOR TO THE START OF THE PROCEDURE. THE HANDPIECE WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED WITHOUT INCID ENT; HOWEVER, THE PROCEDURE WAS DELAYED APPROXIMATELY 45 MINUTES. THERE WAS NO PT INJURY. 9LVAL@5SDURING A LAPARAOSCOPIC CHOLECYSTECTOMY THE CLIPS WERE SCISSORING; TWO ADDITIONAL DEVICES WERE INTRODUCED, WHICH RESULTED IN CLIPS OUT OF THE JAWS AT AN ANGLE. SURGEON COMPLETED CASE WITH A COMPETITOR'S DEVICE. THERE WAS NO CONSEQUENCE TO THE PT, HOEV ER, SURGEON EXPRESSED CONCERN ABOUT THE EVENT. THE DEVICE WAS USED DURING A FEMOROPOPLITERAL BYPASS. THE CLIP CARTRIDGE WAS NOT ACCOUNTED FOR AT THE END OF THE CASE. AN X-RAY WAS TAKEN, HOWEVER, CARTRIDGE WAS NOT LOCATED. THERE WAS NO CONSEQUENCE TO THE PT. 1/3/96: SURGEON REPORTED THAT THE CARTR IDGE FELL ONTO THE FLOOR OR WAS LOST IN THE DRAPE. HE WAS CONFIDENT THAT IT WAS NOT IN THE PT. THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. THE STAPLES DID NOT FORM PROPERLY, WHICH REQUIRED THE ANASTOMOSIS TO BE COMPLETED BY HANDSEWING. THERE WAS NO CONSEQUENCE TO THE PT. THE DEVICE WAS INTRODUCED DURING A LOW ANTERIOR RESECTION. WHEN THE DEVICE WAS OPENED, IT WAS NOTED THAT THE STAPLES WERE PROTRUDING FROM THE TIP. SURGEON ELECTED NOT TO USE THE DEVICE. ANOTHER DEVICE WAS INTRODUCED TO COMPLETE CASE. THERE WAS NO CON SEQUENCE TO THE PT, HOWEVER, SURGEON EXPRESSED CONCERN ABOUT THE EVENT. DURING AN ECTOPIC PREGNANCY THE KNIFE BLADE DETACHED AND REMAINED IN THE PT. THE BLADE WAS RETRIEVED WITHOUT INCIDENT. THERE WAS NO CONSEQUENCE TO THE PT. THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. THE STAPLE LINE DID NOT HOLD, WHICH REQUIRED ANATOMOSIS TO BE COMPLETED BY SUTURING. THERE WAS NO CONSEQUENCE TO THE PT. DURING A LOW ANTERIOR RESECTION THE DEVICE ONLY RELEASED FOUR STAPLES WHEN FIRED. THE REMAINING STAPLES WERE NOT FOUND IN THE DEVICE OR OPERATING SITE; AN X-RAY OF THE PT WAS TAKEN. THERE WAS NO CONSEQUENCE TO THE PT. EVENT NOT REPORTED INTERNALLY UN TIL 1/4/96. DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY SMOKE WAS EMITTED FROM THE JOINT OF THE HANDLE AND SHAFT OF PROBE. THERE WAS NO CONSEQUENCE TO THE PT. EVENT NOT REPORTED INTERNALLY UNTIL 1/5/96. HLVAL1u@i^*NTHE DEVICE WAS UCUSTOMER CLAIMS HER DAUGHTER APPLIED THE HEAT LAMP TO THE CUSTOMER'S TOES FOR A FEW SECONDS. CUSTOMER ASKED THE DAUGHTER TO REMOVE THE DEVICE BECAUSE IT FELT TOO HOT. CUSTOMER DEVELOPED A BLISTER ON HER BIG TOE & A BLISTER ON THE TOE BESIDE IT WHICH SHE HAD BEEN TREATING WITH NEOSPORIN. SINCE THESE BLISTERS WERE STILL RAW 2 WKS LATER, THE CUSTOMER SOUGHT MED TREATMENT FOR THEM ON 1/4/96. THE DR DETERMINED THAT THE CUSTOMER HAD A SECONDARY INFECTION FROM THESE RAW BLISTERS AND PRESCRIBED ANTIBIOT ICS AS TREATMENT. AFTER SWITCHING THE HEAT LAMP TEMPERATURE SWITCH FROM "HI" TO "LO" USER RECEIVED A MILD ELECTRICAL SHOCK. THIS MILD SHOCK CAUSED HIM TO FLINCH INVOLUNTARILY AND DROP THE HEAT LAMP, WHICH FELL TO THE FLOOR ON TOP OF A T-SHIRT AND BURNED IT SLIGHTLY. U SER CLAIMS THAT HIS INVOLUNTARY REACTION RESULTED IN HIS STRAINING HIS SHOULDER AND SO HE SOUGHT MEDICAL ATTENTION FOR THIS INJURY. HIS DR RECOMMENDED SOME MILD STRETCHING EXERCISES TO ALLEVIATE THE SHOULDER STRAIN. DURING AN INCIDENT CALL, THE DEVICE GAVE 3 "NO SHOCK INDICATED" PROMPTS. FROM A REVIEW OF A PRINTOUT FROM A MEDICAL CONTROL MODULE USED DURING THE INCIDENT, THE CUSTOMER'S QA DEPT THOUGHT THE PT'S RHYTHM WAS VENTRICULAR FIBRILLATION. THE CUSTOMER STA TED THERE WAS NO REPORT FROM THE OPERATORS IN THE FIELD OF A MALFUNCTION OF THE UNIT AND THAT THERE ARE NO PT OR INCIDENT DETAILS ARE AVAILABLE. DURING A CATARACT EXTRACTION PROCEDURE, THIS PHACOEMULSIFICATION HANDPIECE FAILED. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. DURING A LAPAROSCOPIC COLON RESECTION. THE DEVICE LOCKED ON TISSUE AND WAS DIFFICULT TO REMOVE. THERE WAS NO CONSEQUENCE TO THE PT, HOWEVER, SURGEON EXPRESSED CONCERN ABOUT THE EVENT. DURING A LAPARAOSCOPIC CHOLECYSTECTOMY THE CLIPS REPEATEDLY HUNG UP AND WOULD NOT RELEASE FROM THE JAWS OF DEVICE. THERE WAS NO CONSEQUENCE TO THE PT, HOWEVER, SURGEON EXPRESSED CONCERN ABOUT THE EVENT. OLVALVl_+fcTHE PLUG HAD SEPARATED FROM THE BODY DURING USE. THERE WA NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER RETURNED ONE SAMPLE TO CO FOR EVAL. EXAMINATION REVEALED THAT THE PLUG WAS NOT SEATED IN THE BODY. IT IS UNCLEAR WHAT CAUSED THIS TO OCCUR. FIRE DEPARTMENT PERSONNEL USED THE UNIT TO MONITOR A PERSON WHO WAS NOT IN A CARDIAC ARREST. AFTER CONNECTING THE PT TO THE UNIT THE 'CONNECT ELECTRODES' MESSAGE WAS DISPLAYED INAPPROPRIATELY. ALL OF THE CONNECTIONS WERE CHECKED AND OBSERVED TO BE SECURE. THE MESSAGE WENT AWAY AND THE PT'S ECG WAS MONITORED SUCCESSFULLY. THERE WERE NO ADVERSE AFFECTS TO PT CARE REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. PHYSIO-CONTROL IS CURRENTLY INVESTIGATING THE REPORTED MALFUNCTION. A PT WITH AN UNSPECIFIED CRITICAL ARRYTHMIA WAS COUNTERSHOCKED FIVE TIMES WITH A DEFIBRILLATOR, WHILE EN ROUTE TO THE HOSP. THE PT WAS ADMITTED TO THE HOSP EMERGENCY DEPARTMENT. THE SAME PARAMEDIC WHO UTILIZED THE DEFIBRILLATOR CONNECTED THE PT TO THIS DEFIBRILLATOR. THE DEVICE WAS USED TO DELIVER A TOTAL OF 14 COUNTERSHOCKS TO THE PT THROUGH STANDARD PADDLES. IT WAS REPORTED WITH NINE OF THESE COUNTERSHOCKS, ENERGY WAS DELIVERED TO THE PT, BUT WITH THE REMAINING FIVE, ENERGY COULD NOT BE DIS CHARGED. THE OBSERVATIONS OR OBSERVATIONS UPON WHICH THIS OPINION WAS BASED HAS NOT BEEN REPORTED. THE PT WAS NOT RESUSCITATED. THE REPORTER STATED THE PT OUTCOME WAS NOT THE RESULT OF THE REPORTED DEVICE DISCREPANCY, BASED UPON A LACK OF PT VIABI LITY. THE DEVICE HAD BEEN INVOLVED IN A REPORT OF SIMILAR NATURE, REFERENCE FIRM CONTROL NUMBER 1995-0905. THE STAFF HAD NOT REQUESTED SERVICEFROM THE FACILITY BIOMEDICAL DEPARTMENT. THE DEVICE HAD REMAINED IN USE AND BECAME THE SUBJECT OF THIS RE PORTED EVENT. SUBSEQUENT TO THIS EVENT, THE REPORTER TESTED THE DEVICE AND OBSERVED PROPER OPERATION. THE REPORTER DECLINED AN OFFER OF SERVICE FROM CO. THE DEVICE WAS RETURNED TO USE. ELVALi[fcFIRST RESPONDERS CONNECTED THE DEVICE TO A PT DURING A RESUSCITATION ATTEMPT. REPORTEDLY THE DEVICE WOULD NOT RECOGNIZE THE PT RHYTHM. ANOTHER DEVICE WAS CONNECTED TO THE PT AND IT "WORKED". NO ADD'L DETAILS REGARDING THE EVENT WERE REPORTED. CO IS C URRENTLY INVESTIGATING THE REPORTED MALFUNCTION. THE DEVICE WAS CONNECTED TO A PT DURING AN ELECTIVE CARDIOVERSION PROCEDURE, THROUGH A EXTERNAL DEFIBRILLATION CABLE. REPORTEDLY, THE DEVICE FAILED TO DELIVER THE SELECTED ENERGY TO THE PT, ON THREE SUCCESSIVE ATTEMPTS. THIS ALLEGATION WAS BASED UPON A LACK OF EXPECTED PT CONVERSION. A BACKUP MONITOR WAS MADE A AVAILABLE AND USED TO SUCCESSFULLY CONVERT THE PT. NO ADD'L DETAIL CONCERNING THE EVENT WAS REPORTED. THE REPORTER ALLEGEDLY OBSERVED AN INTERMITTENT LACK OF DEFIBRILLATOR ENERGY DELIVERY . THE REPORTER ATTRIBUTED THIS FAILURE TO THE DEVICE TRANSFER RELAY ASSEMBLY. THE REPORTER REPLACED THE DEVICE TRANSFER RELAY ASSEMBLY AND OBSERVED PROPER OPERATION THROUGH REPEATED TESTING. THE DEVICE WAS THEN RETURNED TO USE. THE LOCAL FACTORY SERVICE REPRESENTATIVE WAS REQUESTED TO REPAIR A DAMAGED DEVICE DEFIBRILLATION CABLE. REPORTEDLY, THE CABLE WAS DAMAGED BY THE FACILITY, WHEN ATTEMPTING TO REMOVE A BROKEN ELECTRODE POST FROM THE ELECTRODE END. THE REPORTED EVENT OC CURRED DURING A TRAINING SESSION. THE LOCAL FACTORY SERVICE REPRESENTATIVE PROVIDED THE FACILITY WITH TRAINING REGARDING SEPARATION OF AN ELECTRODE FROM THE CABLE, TO HELP PREVENT POST BREAKAGE, AND INSTRUCTED THE FACILITY TO INSPECT THE CABLE ENDS F OR ANY POTENTIAL POST MATERIAL AFTER CABLE-ELECTRODE SEPARATION. THE PRODUCT BROKE DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE MALE LUER DISCONNECTED FROM ANOTHER MFR DEVICE DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE TUBING WAS SPLIT AND LEAKING BLOOD DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. LVAL ,<#;DURING A CATARACT EXTRACTION PROCEDURE, THIS HANDPIECE FAILED TO IRRIGATE. IT WAS EXCHANGED FOR ANOTHER. NO PT INJURY. DURING SET UP PRIOR TO AN OPHTHALMIC PROCEDURE, THE TUBING WAS BLOCKED. NO REPRT OF PT INVOLVEMENT. THE CUTTER FAILED TO FUNCTION AND THAT ASPIRATION WAS EXTREMELY POOR. PROBLEMS WERE FOUND DURING SET UP. NO PT INVOLVEMENT. DURING A CATARACT EXTRACTION PROCEDURE, HANDPIECE FAILED TO FUNCTION PROPERLY. THE HANDPIECE WAS EXCHANGED FOR ANOTHER. NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, THIS HANDPIECE FAILED TO FUNCTION PROPERLY. THE HANDPIECE WAS EXCHANGED FOR ANOTHER. NO PT INJURY. PENCIL WOULD ACTIVATE UPON DEPRESSING THE ROCKER SWITCH BUT WAS NOT OPERATING CONTINOUSLY. THIS SYSTEM DESELECTED THE PHACO MODE DURING A CATARACT EXTRACTION PROCEDURE. ANOTHER SYSTEM WAS USED TO COMPLETE PROCEDURE. NO PT INJURY. THE UNIT WAS SERVICED AND THE LED PANEL WAS REPLACED DUE TO BSS (BALANCED SALT SOLUTION) CONTAMINATION. THE TIP OF THIS HANDPIECE WAS REPORTED TO OVERHEAT DURING AN OPTHALMIC PROCEDRUE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY. THIS HANDPIECE FAILED TO FUNCTION. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE WHICH WAS DELAYED APPROX 10 MINS. NO PT INJURY. DEVICE WAS APPLIED TO A 65-YEAR-OLD FEMALE PT WITH A HISTORY OF CONGESTIVE HEART FAILURE WHO WAS IN CARDIAC ARREST. THE DEVICE REPORTEDLY DISPLAYED "CHECK ELECTRODES" PROMPTS. THE OPERATORS CHECKED THE PADS AND CABLES, AND POWERED THE UNIT OFF AND ON , BUT THE PROMPTS WOULD NOT CLEAR. THE DEVICE WAS THEN REMOVED FROM THE PT. THE PT WAS TRANSPORTED TO A HOSPITAL. DURING TESTING BY THE OPERATORS AT THE START OF THE SHIFT, THE DEVICE SUCCESSFULLY PASSED ITS SELF TEST TWICE. INTERNAL LAYER OF MATTRESS SEPARATED CAUSING A BUBBLE TO FORM UNDER THE PT. THERE WAS NO PT INJURY. ;LVAL%K)pDURING AN OPHTHALMIC PROCEDURE, WHEN THIS PHACOEMULSIFICATION HANDPIECE WAS ACTIVATED, THE MONITOR FOR THE MICROSURGICAL SYSTEM BEING USED WENT "FUZZY" AND THE HANDPIECE WOULD NOT FUNCTION. THERE WAS NO PT INJURY. DURING A CATARACT EXTRACTION PROCEDURE, HANDPIECE FAILED TO CALIBRATE. IT WAS EXCHANGED FOR ANOTHER. NO PT INJURY. THE PROCEDURE WAS INITIATED WITHOUT INCIDENT. THE CATHETER OFFERED SOME RESISTANCE UPON REMOVAL, OVER THE GUIDEWIRE, FROM THE PT. AFTER THE CATHETER WAS SAFELY REMOVED FROM THE PT AN ELONGATION WAS OBSERVED JUST DISTAL TO THE TIP BAN LOCATION. THE AC TUAL COMPLAINT SAMPLE WAS RETURNED FOR EVAL AND FOLLOWING OBSERVATIONS WERE MADE, A VISUAL INSPECTION OF THE TIP SHOWED ELONGATION OF THE SOFT TIP MATERIAL JUST DISTAL TO THE WELD, THE DISTAL TIP ID OF THE RETURN SAMPLE WAS MEASURED AND MAX. GO PIN W AS 0.038", THE THRU-LUMEN WAS MEASURED WITH A 0.035" GUIDEWIRE AND NO RESISTANCE WAS FELT EXCEPT FOR THE ELONGATED SECTION. (THE THRU-LUMEN WAS CHECKED BOTH DISTAL TO PROXIMAL AND PROXIMAL TO DISTAL), A VISUAL INSPECTION OF THE TIP STOCK SHOWED NOTHI NG UNUSUAL (EXCEPT THE ELONGATED SECTION). THE ELONGATION OF THE TIP STOCK MATERIAL IS TYPICAL OF A PULL OF THE TIP STOCK MATERIAL. UNABLE TO FIND ANY MFG DEFICIENCIES WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. INSTRUCTION FOR USE (IC 266) FOR ANGI OGRAPHIC CATHETERS STATES: "NEVER ADVANCE AN ANGIOGRAPHIC GUIDEWIRE OR CATHETER AGAINST RESISTANCE, AS THIS COULD CAUSE VESSEL TRAUMA AND/OR PRODUCT DAMAGE." THIS IS NOT A REPEATED LOT WITHIN THE COMPLAINT TRACKING SYSTEM (1/1/94 - 12/7/95). A REVIEW OF THE RETURNED SAMPLE SHOWED AN ELONGATION OF THE TIP STOCK DISTAL TO THE WELD. THIS CONDITION IS TYPICALLY THE RESULT OF A PULL ON THE MATERIAL. DIMENSIONAL TESTING WAS PERFORMED ON THE CATHETER AND CO WERE UNABLE TO NOTE ANY MFG DEFICIENCIES WHIC H MAY HAVE CONTRIBUTED TO THE COMPLAINT. THE COMPLAINT APPEARS TO BE THE RESULT OF EXCESSIVE FORCE APPLIED TO THE CATHETERS TIP. 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E-Z-EM, INC.MALFUNCTIONNA10708501CARDIOVASCULARDQOF@xwtf^\Q2%   858580960119LIFEPAK DEFIBRILLATOR/MONITORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION59-00285-08CARDIOVASCULARLDDFznmj\RQF2*   858569960119BIRTCHER ABC SINGLE-USE DISPOSABLE NOZZLECONMEDCONMED CORP.MALFUNCTIONNA138030GEN & PLASTIC SURGERYGEIFh@tsp[USH<6   858565960122HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.MALFUNCTIONHS2000900000CARDIOVASCULARMKJF@i]\YKE?4   858562960118FIRST MEDIC SEMI AUTOMATIC DEFILBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION610526-2015-00CARDIOVASCULARMKJF@}|yk`]R>6   858559960120VOLUMETRIC INFUSION PUMP SETMEDEXMEDEX, INC.MALFUNCTIONNAIV3D13GEN HOSPITALFPAF@h\[XLFD9.)   858558960120VOLUMETRIC INFUSION PUMP SETMEDEXMEDEX, INC.MALFUNCTIONNAIV3D13GEN HOSPITALFPAF@h\[XLFD9.)   85855796012012 CC CONTROL SYRINGE WITH MALE LUER LOCKMEDEXMEDEX, INC.MALFUNCTIONNAMX357GEN HOSPITALFMFF@thgdXSQF;6   858526960119LUER LOCK SYRINGE, 12 CCSHERMEDISHERWOOD MEDICAL CO.MALFUNCTIONNA8881-512936GEN HOSPITALFMFF@uiheYNLA-%   858321960124STORZ DELUXE POSTERIOR VITRECTOMY PACKSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP4800OPHTHALMICMLZF@|polb\ZO;3   858320960124STORZ DELUXE POSTERIOR VITRECTOMY PACKSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP4800AOPHTHALMICMLZF@}qpmc\ZO;3   858319960124STORZ STAINLESS STEEL MICROSEAL PHACOEMULSIFICATIOSTORINSTSTORZ INSTRUMENT CO.MALFUNCTIONNADP8040OPHTHALMICHQCF@|{xnhf[G?   h$T'THIS PHACOEMULSIFICATION HANDPIECE I 859381960123LIFE DEFENSE PLUSMATRMEDIMATRX MEDICAL, INC.MALFUNCTIONNA91140500CARDIOVASCULARLDDF\@l`_\NFD9&   859378960125KODAK Y-OMAT MULTILOADER 300EASTKODAEASTMAN-KODAK CO.MALFUNCTIONXML 300711 1958RADIOLOGYIXWFO@uihe\TMB1)   859360960126LIFEPAK DEFIBRILLATOR AND QUIK-PACE EXTERNAL PACEMPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION8802700-07,802904-04CARDIOVASCULARLDDF@zgf[G?   859358960125LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKERPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION9P805460-01CARDIOVASCULARLDDF?@xwtf][P<4   859357960124FIRST MEDIC SEMI AUTOMATIC DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION510510-2085-00CARDIOVASCULARMKJFY@|{xj_\Q=5   859356960122LIFEPAK DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION59-00285-904CARDIOVASCULARLDDFG@sgfcUJI>*"   859355960122LIFEPAK PATIENT MONITORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION59-00283-958CARDIOVASCULARLDDF@uiheWLK@,$   859354960122LIFEPAK DEFIBRILLATOR/MONITORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION9803800-28CARDIOVASCULARLDDF@ymli[RQF2*   859353960126HEARTSTARTLAERMEDILAERDAL MEDICAL CORP.MALFUNCTIONHS 2000900000CARDIOVASCULARMKJF@j^]ZLF?4   859340960126ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35BGEN & PLASTIC SURGERYGAGF@}|yd__T:.   859339960126ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35WGEN & PLASTIC SURGERYGAGF@mhh]C7   859338960126ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35WGEN & PLASTIC SURGERYGAGF @mhh]C7   859173960124FLEXIFLO II ENTERAL NUTRITION PUMPROSSPRODROSS PRODUCTS DIV. ABBOTT LABORATORIESMALFUNCTION82NAGEN HOSPITALLZHFV@|{xljh]7/  \bhlA@N 859494960126ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35BGEN & PLASTIC SURGERYGAGFi@}|yd__T:.   859493960126PROXIMATE R L PLUS HEAVY WIRE LINEAR STAPLERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONTPH30GEN & PLASTIC SURGERYGDWF@ojj_E9   859457960126TWO-BOTTLE UNDERWATER DRAINAGE SETSHERMEDISHERWOOD MEDICAL CO.MALFUNCTIONNA8884-726200GEN HOSPITALKDQF@srocXVK7/   859456960126SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF@i]\YMF?4   859455960126SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF@i]\YMF?4   859454960126SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF@i]\YMF?4   859453960124CHICK ORTHOPAEDIC SURGICAL TABLEMIDMARKMIDMARK CORP.MALFUNCTION10703NAGEN & PLASTIC SURGERYJEAFK@xlkhSQLA4-   859452960124CHICK ULTRALUX SURGICAL LIGHTMIDMARKMIDMARK CORP.MALFUNCTIONC-20 SINGLE LIGHT HEADNAGEN & PLASTIC SURGERYFQPF@zyva_I>1*   859451960124CHICK-LANGREN ORTHOPAEDIC AND SURGICAL TABLEMIDMARKMIDMARK CORP.MALFUNCTION10500UNKGEN & PLASTIC SURGERYJEAF@yxu`]XM@9   859450960126T CONNECTOR WITH MALE LUER SLIPMEDEXMEDEX, INC.MALFUNCTIONNAMX453GEN HOSPITALFOZF@j^]ZNIG<1,   859405960125LIFEPAK DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION6S801585-17CARDIOVASCULARLDDF@rfebTKI>*"   859394960125LIFEPAK BATTERY PAKPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION300804901CARDIOVASCULARLDDFN@nba^PJG<(   859385960125LIFE DEFENSE PLUSMATRMEDIMATRX MEDICAL, INC.MALFUNCTIONNA91140500CARDIOVASCULARLDDF@l`_\NFD9&   859383960123MILLS MAMMARY TISSUE FORCEPSVMUELV. MUELLER DIV. BAXTER HEALTHCARE CORP.MALFUNCTIONUNKCH8770GEN & PLASTIC SURGERYGENF @~ic`U.)  O ^#EsPARAMEDICS CONNECTED THE DEVICES TO THE PT IN A NURSING HOME. THE PT H 859641960122VOLUMETRIC INFUSION PUMP SETMEDEXMEDEX, INC.MALFUNCTIONNAIV5L03GEN HOSPITALFPAFo@h\[XLFD9.)   859639960123LIFEPAK DEFIBRILLATOR/MONITOR/PACEMAKERPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION9P805460-01CARDIOVASCULARLDDF@@xwtf][P<4   859636960118LIFEPAK DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTIONNAUNKCARDIOVASCULARLDDF@l`_\NKI>*"   859635960122LIFEPAK AUTOMATIC ADVISORY DEFIBRILLATORPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION300804900-03CARDIOVASCULARMKJF@zyvh_\Q=5   859510960126BRONCHO-CATHMALLMEDIMALLINCKRODT ANESTHESIOLOGY DIV.MALFUNCTIONNA95892ANESTHESIOLOGYCBIF@qedaSNLA!   859508960126ENDOPATH DISPOSABLE SURGICAL TROCARETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTION512XGEN & PLASTIC SURGERYGCJF@~}zeaaV<0   859505960126ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35BGEN & PLASTIC SURGERYGAGF@}|yd__T:.   859504960126ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35WGEN & PLASTIC SURGERYGAGF@mhh]C7   859503960126ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35WGEN & PLASTIC SURGERYGDWF@mhh]C7   859502960126ENDOPATH DISPOSABLE SURGICAL TROCARETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTION512XGEN & PLASTIC SURGERYGCJFJ@~}zeaaV<0   859499960126ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35WGEN & PLASTIC SURGERYGAGF@mhh]C7   859497960126ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35BGEN & PLASTIC SURGERYGAGF@}|yd__T:.   859495960126ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35WGEN & PLASTIC SURGERYGDWF$@mhh]C7  }&61THESE TYPES 860918960202YALE-NEW HAVEN MEDICAL CENTER CUSTOM SETMEDEXMEDEX, INC.MALFUNCTIONNAMX6349-1GEN HOSPITALFPAFC@vjifZRPE:5   860840960111DYNAMOMETER EXERCISE SYSTEMBIODMEDISYSTBIODEX MEDICAL SYSTEMS, INC.MALFUNCTION900-220NAPHYS MEDBXBF@|poldb[P4(   859697960124SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF~@i]\YMF?4   859696960124SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-776ASM-776GEN HOSPITALFNMF@i]\YMF?4   859695960124SOF-CAREGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONSC-440SC-440GEN HOSPITALFNMF@g[ZWKE?4   859694960124SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF@i]\YMF?4   859693960124SOF-CAREGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONSC-427SC-427GEN HOSPITALFNMFx@g[ZWKE?4   859692960124SOF-CAREGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONSC-427SC-427GEN HOSPITALFNMF@g[ZWKE?4   859691960124SOF-CAREGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONSC-427SC-427GEN HOSPITALFNMF@g[ZWKE?4   859690960124SOF MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONPSM-180PSM-180GEN HOSPITALFNMF@i]\YMF?4   859689960124SOF-CAREGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONSC-460SC-460GEN HOSPITALFNMF@g[ZWKE?4   859647960124LIFEPAK DEFIBRILLATOR QUIK-PACE EXTERNAL NONINVASIPHYSCONTPHYSIO-CONTROL CORP.MALFUNCTION8802700-16, 802800-26CARDIOVASCULARLDDFv@{gf[G?   859645960124CUSTOM CT ADMINISTRATION SETMEDEXMEDEX, INC.MALFUNCTIONNAMX7155GEN HOSPITALFPAFx@h\[XLFD9.)   859643960123TRIFURCATED ADAPTOR SETMEDEXMEDEX, INC.MALFUNCTIONNAMX6726GEN HOSPITALFPAF*@cWVSGA?4)$   859642960123VOLUMETRIC INFUSION PUMP SETMEDEXMEDEX, INC.MALFUNCTIONNAIV1A09GEN HOSPITALFPAF@h\[XLFD9.)  LVALUPDEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY/REDUCTION OF INFARCTION. THE STAPLES DID NOT FORM ON THE SECOND FIRING AND THE INDIVIDUAL STAPLES HAD TO BE REMOVED FROM THE PT. NO CONSEQUENCE TO THE PT. DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATON. AT THE COMPLETION OF THE PROCEDURE, IT WAS FOUND THAT THE TROCAR TIP HAD SHATTERED INTO MULTIPLE FRAGMENTS. MOST OF THE FRAGMENTS WERE REMOVED FROM PT'S ABDOMEN, HOWEVER, SURGEON EXPRESSED C ONCERN THAT SEVERAL PIECES MAY STILL BE PRESENT. NO CONSEQUENCE TO THE PT. DEVICE WAS USED DURING AN ABDOMINAL HYSTERECTOMY. THE CASE BEGAN AS A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BUT WAS CONVERTED TO AN OPEN PROCEDURE DUE TO ADHESIONS. THE DEVICE WAS FIRED AND THERE WAS STAPLE LINE BLEEDING IN THE MIDDLE OF THE ST APLE LINE. NO CONSEQUENCE TO THE PT. TWO OF 7 UNOPENED CDU UNITS THAT WERE VISUALLY INSPECTED FOR PROPER/INCORRECT ASSEMBLY CONTAINED IMPROPER TUBE ASSEMBLY. CUSTOMER DEPICTED THAT THE OPPOSITE END OF THE CONNECTING TUBE WAS ATTACHED TO THE WATER SEAL TUBE OF THE SECOND BOTTLE (INSTEAD OF TO THE PT TUBE) AND THE PT DRAINAGE TUBE WAS ATTACHED TO THE CAP INSERT (INSTEAD OF TO THE WATER SEAL TUBE). THERE WAS NO REPORT OF INJURY OR PT INVOLVEMENT. NO FURTHER INFO WAS PROVIDED. THE SURGEON WAS PERFOMING A TIBAL NAILING ON A 170 POUND MALE PT ON THE TABLE. THE HORIZONTAL PERINEAL POST WAS PLACED UNDER THE KNEE TO SUPPORT IT DURING THE PROCEDURE. THE PT'S LEG WAS PLACED IN TRACTION OVER THE POST. THE DR COMPLETED THE PROCEDUR E UP TO THE POINT OF PLACING THE NAIL THROUGH THE TIBIA. THE DR WAS ALMOST FINISHED WHEN THEY HEARD A LOUD CRACK. THE SURGICAL TEAM NOTICED THAT THE POST UNDER THE KNEE HAD CRACKED WHERE IT ATTACHED TO ITS BASE. THE DR REPLACED THE POST WITH AN OLDER ONE AND FINISHED THE PROCEDURE. NO INJURIES WERE REPORTED DUE TO THIS INCIDENT. LVAL'8#;DURING A CATARACT EXTRACTION PROCEDURE, TA DRYER THE TUBING SEPARATED FROM THE DEVICE DURING USE. NO PT INJURY OR TREATMENT. THE CUSTOMER DID NOT RETURN SAMPLES TO CO FOR EVALUATION. WAS UNABLE TO CONFIRM THIS COMPLAINT OR DETERMINE THE CAUSE. THE CASSETTE WAS BROKEN. BLOOD SEEPED OUT. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. EMERGENCY PERSONNEL RESPONDED TO A PERSON DESCRIBED AS IN FULL CARDIAC ARREST. THE PT WAS CONNECTED TO THE DEVICE AND WAS DIAGNOSED AS IN ASYSTOLE. CPR WAS PERFORMED AND DRUGS ADMINISTERED AS THE PT WAS TRANSPORTED TO THE HOSP. DURING CPR, THE PT'S R HYTHM CONVERTED TO COARSE VENTRICULAR FIBRILLATION, THE AMBULANCE PULLED OF THE ROAD AND THE "PUSH TO ANALYZE" BUTTON WAS PRESSED. ACCORDING TO THE REPORTER, THE DEVICE ADVISED NO SHOCK AND THE PT'S RHYTHM DETERIORATED. A BACKUP MANUAL DEFIBRILLATOR WAS CALLED FOR AND USED. THE PT WAS RESUSCITATED. IN EVAL OF THE DEVICE BY THE LOCAL CO SERVICE REPRESENTATIVE, A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PROPER OPERATION WAS OBSERVED. CASSETTE AND CHART RECORDINGS OF THE REPORTED EVENT WERE EVALU ATED BY CO AND SEVERAL "MOTION DETECTED" ALARMS WERE OBSERVED DURING THE DEVICE'S RHYTHM ANALYSIS. PROPER OPERATION OF THE DEVICE WAS REVIEWED WITH THE FACILITY AND THE UNIT RETURNED TO THE CUSTOMER FOR USE. DIFFICULTY IN PLACING THE REPORT DEVICE. THE USER CHOSE TO USE A DIFFERENT DEVICE. THE PT WAS REINTUBATED. NO INJURY TO THE PT REPORTED. REINTUBATION IS A ROUTINE AND WELL UNDERSTOOD PROCEDURE. THE PHYSICIAN HAS REPORTED A USER PREFERNCE IN THE TIP S TYLE OF THE REPORT DEVICE. DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE TROCAR BROKE INTO SEVERAL PIECES INSIDE THE PT'S ABDOMEN. IT IS NOT CERTAIN IF ALL THE PIECES WERE RETRIEVED. NO CONSEQUENCE TO THE PT, HOWEVER, SURGEON EXPRESSED CONCERN ABOUT THE EVENT. LVALo@@DURING AN OPHTHALMIC PROCEDURE, WHENUNIT WILL NOT RUN FOR MORE THAN 5 MINS ON ANY BATTERY. NO PT COMPROMISE. UNABLE TO VERIFY CUSTOMER THE UNIT WAS USED IN AN ATTEMPT TO ADMINISTER A SYNCHRONIZED COUNTERSHOCK TO A PT (CONDITION AND DIAGNOSIS NOT REPORTED) UNDERGOING A CARDIOVERSION PROCEDURE. WHEN THE OPERATOR ATTEMPTED TO ADMINISTER THE COUNTERSHOCK, THE UNIT ALLEGEDLY FAILED TO DI SCHARGE AND THE OPERATOR OBSERVED THAT THE CHARGE INDICATOR WAS FLASHING AND DID NOT COME ON STEADY. THE OPERATOR PRESSED THE CHARGE SWITCH ON THE DEFIBILLATOR FRONT PANEL REPEATEDLY. THE UNIT ALLEGEDLY FAILED TO COMPLETE CHARGING. POWER TO THE UNIT WAS CYCLED AND THE UNIT CHARGED PROPERLY TO THE SELECTED ENERGY AND DISCHARGED NORMALLY. THE PT WAS SUCCESSFULLY CARDIOVERTED. THE HOSP BIOMED ENGINEERING STAFF EVALUATED THE UNIT AND WERE NOT ABLE TO DUPLICATE OR CONFIRM THE ALLEGED MALFUNCTION. CO SUBSEQUENTLY EVALUATED THE UNIT. PERFORMANCE AND FUNCTIONAL TESTING WAS DONE. THE DEVICE WAS OBSERVED TO OPERATE PROPERLY. THE ALLEGED MALFUCTION WAS NOT DUPLICAED OR CONFIRM. THE POWER CONVERSION PCB ASSEMBLY AND THE TRANSFER RELAY ASSEMBLY WERE REP LACED AS A PREVENTATIVE MEASURE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO CUSTOMER. A MALE HOUSKEEPER ALLEGEDLY SHOCKED HIMSELF WITH AN UNSPECIFIED CO'S DEFIBRILLATOR. THE GUARD INDICATED THE PERSON PICKED UP THE DEFIBRILLATOR PADDLES AND SHOCKED HIMSELF INTENTIONALLY. THE PERSON WAS ADMITTED TO THE FACILITY AND AFTER AN UNSPECIFIED TIME WAS DETERMINED TO BE IN GOOD HEALTH. THE DEVICE HAS NOT BEEN IDENTIFIED AND IT IS NOT LIKELY THAT ANY ADD'L INFO CONCERNING THE EVENT WILL BE REPORTED TO CO. THE LOCAL FACTORY SVC REP CONTACTED THE FACILITY RISK MGR REGARDING THE ALLEGATION. TH E MGR ACKNOWLEDGED A PERSON HAD SELF ADMINISTERED A DEFIBRILLATOR SHOCK. THE RISK MGR INDICATED THAT WITHOUT ANY MORE SPECIFIC INFO FROM THE REP TO IDENTIFY THE EVENT, IT WOULD NOT BE POSSIBLE TO OBTAIN ANY ADD'L EVENT INFO FROM THE FACILITY. LVAL^%T'INTERIOR WELD SEPERATED CAUSING A BUBBLE TO FORM IN THE SURFACE OF THE PAD. TESTING CONFIRMS INNER CELL SEPARATION. MFR DATE 11/94. INNER LAYER OF UPPER MATTRESS CELL CAME APART CAUSING A BUBBLE TO FORM IN THE SURFACE OF THE MATTRESS. TESTING CONFIRMS INNER CELL SEPARATION. MFR DATE : 12/1974. INNER LAYER OF MATTRESS SEPARATED CAUSING A BUBBLE TO FORM IN MATRESS SURFACE. TESTING CONFIRMS INNER CELL SEPARATION. DEVICE MFR DATE: 7/95. THE MALE LUER DISCONNECTED FROM ANOTHER MFR'S DEVICE DURING USE. NO PT INJURY OR TREATMENT. THE CUSTOMER RETURNED NO SAMPLES TO CO FOR EVALUATION. RETAINED SAMPLES WERE EVALUATED AND THE LOT HISTORY WAS REVIEWED. ALL UNITS WERE ACCEPTABLE PER SPECIFI CATIONS. THIS PRODUCT IS TESTED TO 20 PSI. IT IS NOT DESIGNED TO WITHSTAND HIGHER PRESSURES. THE CUSTOMER STATED THE THE USAGE PRESSURES WERE GREATER THAN 300 PSI. THIS ISSUE WILL BE ADDRESSED WITH THE CUSTOMER. CO WAS UNABLE TO CONFIRM THIS COMPLAIN T. BASED UPON THE ABOVE INFORMATION, CO DETERMINED THAT THIS ISSUE IS BEING ADDRESSED, AND NO ADDITIONAL ACTION IS NECESSARY. THE MALE LUER SEPARATED FROM THE FEMALE LUER OF ANOTHER MFR'S THREADED LOCK CANNULA DURING USE. NO PT INJURY OR TREATMENT. EVALUATION OF THE RETURNED UNIT REVEALED THAT THE CO'S MALE LUER AND THE MATING PART BOTH CONFORMED TO THE ANSI SPECIFICATIONS. THE LOT NUMBER OF THE UNIT INVOLVED WAS UNKNOWN, MAKING FURTHER LOT EVALUATION IMPOSSIBLE. CO IS CURRENTLY ADDRESSING THIS ISSUE THROUGH INTENSIVE INSERVICING OF THE CLINICAL STAFF AT THIS PARTICULAR HOSP. IT IS POSSIBLE THAT THIS IS A USER TECHNIQU E ISSUE ASSOCIATED WITH THE CLINICAL STAFF'S PERCEPTION THAT THEY HAVE MADE A SECURE CONNECTION WHEN PERHAPS THEY HAVE NOT. TO THAT END, CO IS WORKING WITH THE STAFF AT THIS HOSP TO DETERMINE IF ANOTHER CONFIGURATION OF MALE LUER WOULD PROVIDE A MORE USER FRIENDLY CONNECTION TO THEIR PARTICULAR STAFF. LVALzINTERNAL LAYER INNER LAYER OF CELL SPLIT CAUSING A BUBBLE TO FORM IN THE SURFACE OF THE MATTRESS. TESTING CONFIRMS INNER CELL SEPARATION. DATE:4/95. INNER LAYER OF MATTRESS SEPERATED CAUSING A BUBBLE TO FORM IN MATTRESS SURFACE. TESTING CONFIRMS INNER CELL SEPARATION. DATE: 7/94. INNER LAYAER OF CELL SPLIT CAUSING A BUBBLE TO FORM IN THE SURFACE OF THE MATTRESS. TESTING CONFIRMS INNER CELL SEPARATION. INTERIOR WELD SEPARATED CAUSING A BUBBLE TO FORM IN THE SURFACE OF THE PAD. TESTING CONFIRMS INNER CELL SEPARATION. INTERIOR WELD SEPARATED CAUSING A BUBBLE TO FORM IN THE SURFACE OF THE PAD. DEVICE MFR DATE: 10/94. TESTING CONFIRMS INNER CELL SEPARATION. FACILITY STAFF WERE PACING A PT WITH THE EQUIPMENT. PT CONDITION WAS NOT REPORTED. A LOW BATTERY MESSAGE WAS DISPLAYED. REPORTEDLY, WHEN THE OPERATOR PLUGGED THE DEFIBRILLATOR/MONITOR INTO AC POWER, THE ATTENDING STAFF SAW CHEST CONTRACTION, AND THE PT YELLED OUT. THE REPORT IS NOT CLEAR AS TO WHETHER THE PACER WAS PACING AT THE TIME. IT WAS ALLEGED THE PT HAD RECEIVED SOME TYPE OF SHOCK THROUGH THE APPLIED PACER PADS. IT WAS ALSO REPORTED THAT THE MONITOR SIMULTANEOUSLY DISPLAYED A SQUARE WAVE ON THE CRT. USE OF THE EQUIPMENT WAS DISCONTINUED AND THE PT WAS PACED WITH ANOTHER DEVICE. THE REPORTER INDICATED THAT NO ADVERSE AFFECTS TO THE PT RESULTED FROM THE REPORTED EVENT. THE EQUIPMENT AND A STRIP RECORDED AT THE TIME OF THE REPORTED EVEN T WERE GIVEN TO THE LOCAL CO SERVICE REP FOR EVALUATION. THE SERVICE REP OBSERVED PROPER EQUIPMENT OPERATION, THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE STRIP WAS IDENTICAL TO THAT MADE BY THE MONITOR AT POWER UP, SHOWING A TYPICAL SQUARE W AVE CALIBRATION PULSE. A SUBSEQUENT EVALUATION BY MFR SITE OBSERVED NO DISCREPANCIES RELATED TO THE REPORT. ADDITIONAL CATNO: 802904-04. LVALTHERE WAS WHITE PARTICULATE FOUND IN THE IV TUBING. THE REPORTER FELT THAT THE PARTICULATE WAS LIKELY BEING SHEARED OFF OF THE INSIDE OF THE INJECTION CAP DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. UNIT DISPLAYED ERROR CODE 001 DURING TESTING. H.V.TRANSFORMER SHORTED. REPLACED TRANSFORMER UNIT FUNCTIONS CORRECTLY. UNIT UNIT PREMATURELY DISCHARGES. DISCOVERED DURING TESTING. CONNECTOR CN 4 ON ANALOG BOARD HAD VARYING CONTACT RESISTANCE. REPLACED CN 4 HEADER & MATING FEMALE RECEPTACLES. UNIT FUNCTIONS PROPERLY. FEMALE PT, DOB 5/9/60, WAS BEING SET-UP ON EXERCISE MACHINE FOR TREATMENT OF LEFT FOOT/ANKLE. WHEN ATTEMPTING TO SET RANGE OF MOTION LIMITS, THE MACHINE FORCEFULLY ROTATED IN THE COUNTER-CLOCKWISE DIRECTION AND THEN LOCKED IN THAT POSITION. X-RAY LEF T FOOT UNREMARKABLE. HISTORY OF FRACTURE LEFT FOOT. DEVICE MFR 1/89. CUSTOMER DID NOT HAVE A SERVICE CONTRACT. LAST PREVIOUS SERVICE CALL WAS ON JUNE 20, 1993 BECAUSE MOTOR WAS NOISY. SERVICE RESET TACHOMETER BRUSHES. STANDARD PRACTICE IS TO ASK CUST OMER IF THEY WANT A PREVENTIVE MAINTAINENCE DONE WHILE THERE FOR AN ADDITIONAL CHARGE. CUSTOMER SAID, "NO". DID NOT WANT TO PAY ADDITIONAL FEE. FOLLOWING PROBLEM REPORT CALL ON JUNE 21, 1995, DID SERVICE CALL ON JUNE 27, 1995. UNIT HAD FIVE(5) FRONT PANEL LIGHTS OUT. FOUND P-7 ROM POT OUT OF TOLERANCE. REPLACED LIGHTS AND DID PREVENTIVE MAINTAINENCE. UNIT NOW WORKED FINE. LIGHTS ARE NEEDED TO SHOW WHAT TO DO NEXT ON MACHINE FOR SET-UP AND USE. WITHOUT THE LIGHTS YOU DO NOT KNOW WHERE THE SYSTEM IS SET EXCEPT BY GUESSING. HOSP DID X-RAY ON PT. NO PROBLEM WITH ANKLE. CUSTOMERS NORMALLY REPLACE BULBS THEMSELVES. SERVICE CONTRACTS AND PREVENTATIVE MAINTAINENCES ARE RECOMMENDED TO CUSTOMERS. INNER LAYER OF CELL SPLIT CAUSING A BUBBLE TO FORM IN SURFACE OF THE MATTRESS. TEST CONFIRMS CELL SEPARATION. DATE: 9/95. LVAL}DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. DEVICE LOCKED ON TISSUE AND WAS DIFFICULT TO OPEN, WHICH RESULTED IN A POOR STAPLELINE. HEMOSTASIS WAS ACHIEVED WITH ENDOLOOP AND CAUTERY. NO CONSEQUENCE TO THE PT. A PT WAS ADMITTED TO THE FACILITY EMERGENCY ROOM. AN UNSUCCESSFUL ATTEMPT HAD BEEN MADE TO ACHIEVE PT CAPTURE WITH ANOTHER MFR'S PACER, IN TRANSIT TO THE FACILITY. THE PT WAS DESCRIBED AS IN FULL ARREST AT ADMITTANCE. THE EQUIPMTHE DEVICE LEAKED DURING INJECTION OF RADIOACTIVE MATERIAL. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. DISPLAYED EXCESSIVE ARTIFACT DURING USE ON A PT (T CONDITION AND DIAGNOSIS NOT REPORTED). THE OPERATOR CHANGED THE PT CABLE WITH NO IMPROVEMENT IN THE DISPLAYED ECG. A BACKUP PT MONITOR WAS MADE AVAILABLE AND USED WITH NO OTHER PROBLEMS REPORTED. THE PT WAS DESCRIBED AS OK. THE SERVICE REP EVAL THE UNIT AND OBSERVED THAT THE PT CABLE CONNECTOR KEY WAS WORN/BROKEN AWAY. THE PT CABLE COULD BE PLUGGED IN ANY ORIENTATION. THE PT CABLE CONNECTOR WAS REPLACED. FOLLOWING THE REPAIRS, PROPER OPERATION W AS OBSERVED WAS OBSERVED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. THE TUBING SEPARATED FROM THE STOPCOCK DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER RETURNED ONE UNUSED AND ONE USED SAMPLE FOR EVALUATION. EXAMINATION OF THE RETURNED USED UNIT REVEALED THAT THE TUBING WAS SEPARATED FROM THE STOPCOCK BECAUSE THE TUBING HAD NOT BEEN INSERTED FAR ENOUGH INTO THE TUBING PORT TO ENSURE A SECURE CONNECTION. CO'S PRODUCTION PERSONNEL WERE NOTIFIED OF THIS ISSUE. EXAMINATION OF THE RETUNRED UNUSED UNIT REVEALED THAT THE TUBI NG WAS SECURE INSIDE THE STOPCOCK AND EXCEEDED CO'S MINIMUM SPECIFICATION FOR PULL TESTING. CO'S WAS ABLE TO CONFIRM THIS ISSUE AND DETERMINE THE CAUSE. BASED UPON THIS INFO, CO'S BELIEVES THAT THIS ISSUE IS BEING ADDRESSED AND THAT NO ADDITIONAL ACT ION IS NECESSARY AT THIS TIME AND CONSIDERS THIS MDR CLOSED WITH THIS REPORT. LVAL  !TFACILITY STAFF CONNECTED THE DEVICE TO A PT THROUGH A DEFIBRILLATION CABLE, DURING A CARDIOVERSION ATTEMPT. THE DEVICE WAS OPERATING ON AC POWER AT THIS TIME. WHEN THE DEFIBRILLATOR DISCHARGED, THE CRT DISPLAY CEASED TO ILLUMINATE. AFTER SEVERAL SECO NDS, THE OPERATOR CYCLED POWER AND PROPER DISPLAY RETURNED. NO ADDITIONAL DETAILS CONCERNING THE EVENT WERE REPORTED. A BACKUP DEFIBRILLATOR/MONITOR WAS MADE AVAILABLE AND WAS USED TO SUCCESSFULLY CONVERT THE PT. THE REPORTER OBSERVED PROPER DEVICE O PERATION DURING AN EVAL. THE DEVICE WAS SUBSEQUENTLY GIVEN TO THE LOCAL CO SERVICE REP FOR EVAL. THE SERVICE REP OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE FACILITY FOR USE. THE CATHETER DID NOT REFORM IN A 71 YR OLD MALE PT AFTER THE GUIDEWIRE WAS REMOVED. THE CATHETER WAS NOT STRAIGHTENED UNTIL JUST BEFORE IT WAS PLACED ON THE GUIDEWIRE AND WAS NOT LEFT ON THE WIRE FOR AN EXTENDED PERIOD OF TIME. THE CATHETER WAS REMOV ED AND ANOTHER USED WITHOUT INCIDENT. THE LOT HISTORY RECORD WAS REVIEWED. THIS LOT FAILED IN-PROCESS QA INSPECTION FOR SHAPE. THE LOT WAS REWORKED BY HEATING AND CHILLING OF APPROX 150 CATHETER'S SHAPES. THE LOT THEN ASSED A TIGHTENED INSPECTION ON THE CATHETER'S SHAPES. THE INCOMING RECEIVNG LOT OF TIP STOCK WAS ALSO REVIEWED FR ANY ABNORMALITIES WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING WAS OBSERVED. THE SHAPE ON THE COMPLAINT SAMPLE HAS NOT REFORMED TO AN ACCEPTABLE CONDITION. THE FILM OF THE PROCEDURE SHOWED THAT THE SHAPE AT THE TIME OF THE PICTURE HAD NOT REFORMED. NINE (9) STOCK SAMPLES WERE ALSO RETURNED WITH THIS COMPLAINT. AN ENGINEERING ANALYSIS IS CURRENTLY UNDERWAY. THIS IS THE FIRST COMPLAINT FOR THIS MFG LOT NUMBE R WITHIN THE COMPLAINT TRACKING SYSTEM (1/1/94-2/1/96). THIS IS THE FIFTH REPORTED COMPLAINT FOR THE PRODUCT FAMILY FOR (SHAPE/REFORMING) WITHIN THE COMPLAINT TRACKING SYSTEM. A CONCLUSION/ FOLLOW-UP WILL BE MADE UPON THE FINAL RESULTS OF THE ENGINEE RING ANALYSIS. LVALhlA@N 859494960126ENDOPATH ENDOSCOPIC LINEAR CUTTERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONEZ35BGEN & PLASTIC SURGERYGAGFi@A}|yd__T:.   859493960126PROXIMATE R L PLUS HEAVY WIRE LINEAR STAPLERETHIENDOSURGETHICON ENDO-SURGERY, INC.MALFUNCTIONTPH30GEN & PLASTIC SURGERYGDWF@Aojj_E9   859457960126TWO-BOTTLE UNDERWATER DRAINAGE SETSHERMEDISHERWOOD MEDICAL CO.MALFUNCTIONNA8884-726200GEN HOSPITALKDQF@EsrocXVK7/   859456960126SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF@Ai]\YMF?4   859455960126SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF@Ai]\YMF?4   859454960126SOF-MATTGAYMINDUGAYMAR INDUSTRIES, INC.MALFUNCTIONASM-780ASM-780GEN HOSPITALFNMF@@i]\YMF?4   859453960124CHICK ORTHOPAEDIC SURGICAL TABLEMIDMARKMIDMARK CORP.MALFUNCTION10703NAGEN & PLASTIC SURGERYJEAFK@ExlkhSQLA4-   859452960124CHICK ULTRALUX SURGICAL LIGHTMIDMARKMIDMARK CORP.MALFUNCTIONC-20 SINGLE LIGHT HEADNAGEN & PLASTIC SURGERYFQPF@Dzyva_I>1*   8594519HOSP PERSONNEL USED THE UNIT TO PACE A PT. PACING WAS INITIATED AND THE PT PACED FOR SOME PERIOD OF TIME. AFTER THAT ALLEGEDLY THE UNIT INDICATED A PACING LEADS OFF ALARM AND PACING STOPPED. THE OPERATOR RESTARTED THE PACER AND PACING CONTINUED WITHO UT FURTHER COMPLAINT. THE OPERATOR INDICATED THERE WERE NO ADVERSE EFFECTS TO THE PT AS A RESULT OF THE ALLEGED MALFUNCTION. CO HAS EVALUATED THE UNIT AND OBSERVED PROPER OPERATION. THE PACING CABLE USED DURING THE DESCRIBED EVENT WAS EVALUATED AND T HE PACING ELECTRODE CONNECTORS WERE OBSERVED TO BE WORN AND DAMAGED FROM USE. THE PACING CABLE HAS BEEN REPLACED. THE CONDITION OF THE PACING CABLE COULD POSSIBLY HAVE CONTRIBUTED TO THE DESCRIBED EVENT, BUT DURING TESTING BY CO THE CABLE FUNCTIONED PROPERLY. 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THE STRIP WAS IDENTICAL TO THAT MADE BY THE MONITOR AT POWER UP, SHOWING A TYPICAL SQUARE W AVE CALIBRATION PULSE. A SUBSEQUENT EVALUATION BY MFR SITE OBSERVED NO DISCREPANCIES RELATED TO THE REPORT. ADDITIONAL CATNO: 802904-04.  itbm olkwuB awuGawuh awuh awuh awunawuawuawuawuawvh awvh a|a a}d+b`l2 b`| bajbajbajbal@balBbgu+ dtrFdtrhdtrdtr dtr dtrduvjduvoduwduw+du|du| du|A du|A du|C du|C dvs dvs&dvs2dvs2dvvn dwadwa dwa2 dwf dw~Cd{m2 d|} d}h+ d}hDfmbk fv{8gdghgdghgdghggvhgjj+gjjE gltigmg@gmvgmv# gmv# gogFgoggoggoh2goh2gohE gohkgohkgohgohgpm gpm+ gpokgpogpo gpo gpogpogpogpogpogpo gpo gpo gpo grvEgrvk gr~# gr~@ gr~gs`gs`# gs`# gs`Cgs`Dgs`jgs`k gs`l gs`l gs`lgs`ogs`o gs`o gs`gs`gs` gs`gs`gs`gs`gs`gsdgsrgsr8gsrEgsrkgsrkgsrgtsgup+ gup2gupC gv`8gv`Dg{ooh`h h`h h`h h`h h`h h`h h`h h`h8h`h8h`h@h`hD h`hE h`hFh`hFh`hlh`hlh`hnh`hnh`hnh`hn h`hoh`hh`hh`hh`h h`hh`hh`hh`hhbk hbk@ hbk@ hbkD hbkD hbkE hbkFhbknhbkhbkhdr8hdr8hdrD hdrEhdrn hdrn hd{nhd{ hd{hd{hfj2hfj8 hfjAhfjBhfjihfjihfjihfji hfji hfjj hfjlhfjlhfjlhfjl hfjnhfj hfj hfj hfphfvjib}kifaFiho@ ikakitb@itbFitbF itbGitbGitbG itbiitbiitbjitbjitbj itbj itbkitbmitbmitbm itbm itbm fj awoCawr2awuAawuB awuGawuh awuh awuh awunawuawuawuawuawvh awvh a|a a}d+b`l2 b`| bajbajbajbal@balBbgu+ dtrFdtrhdtrdtr dtr dtrduvjduvoduwduw+du|du| du|A du|A du|C du|C dvs dvs&dvs2dvs2dvvn dwadwa dwa2 dwf dw~Cd{m2 d|} d}h+ d}hDfmbk fv{8gdghgdghgdghggvhgjj+gjjE gltigmg@gmvgmv# gmv# gogFgoggoggoh2goh2gohE gohkgohkgohgohgpm gpm+ gpokgpogpo gpo gpogpogpogpogpogpo gpo gpo gpo grvEgrvk gr~# gr~@ gr~gs`gs`# gs`# gs`Cgs`Dgs`jgs`k gs`l gs`l gs`lgs`ogs`o gs`o gs`gs`gs` gs`gs`gs`gs`gs`gsdgsrgsr8gsrEgsrkgsrkgsrgtsgup+ gup2gupC gv`8gv`Dg{ooh`h h`h h`h h`h h`h h`h h`h h`h8h`h8h`h@h`hD h`hE h`hFh`hFh`hlh`hlh`hnh`hnh`hnh`hn h`hoh`hh`hh`hh`h h`hh`hh`hh`hhbk hbk@ hbk@ hbkD hbkD hbkE hbkFhbknhbkhbkhdr8hdr8hdrD hdrEhdrn hdrn hd{nhd{ hd{hd{hfj2hfj8 hfjAhfjBhfjihfjihfjihfji hfji hfjj hfjlhfjlhfjlhfjl hfjnhfj hfj hfj hfphfvjib}kifaFiho@ ikakitb@itbFitbF itbGitbGitbG itbiitbiitbjitbjitbj itbj itbkitbmitbmitbm itbm itbm fj itbnitbnitboitbitbitbitbitbitb itb itb itb itbitf&itf&itfC itfGitfGitfGitfhitfiitfj itfj itfkitfmitfmitfmitfmitfm itfitfitf itfitm2itmB itrG it}Biul iuo@ iu|Bi{oijl}2jmrGjm}ojm}ojru&jru2 jru@jruA juwj|{ j}fG j}|hj}|l j~iFj~thj~thkdp+kdpAkf`kf`kfakft&l`fG lapF ldt lg~DlpvE lpw@lpwilsrB lsrB lui#lui#lui+l|kAl}hF l}h l}h mdd&mdd& mdd& mdd& mdd+mdd2mdd8mdd8 mdd@mddA mddBmddCmddCmddEmddhmddi mddi mddjmddjmddjmddkmddlmddl mddmmddmmddomddo mddmddmddmdd mdd mddmddmddmddmdd mddmddmddmdd mdd mdd mddmddmddmdd mdd mddmddmddmddmddmddmgkB mjw#mog+mrdEmrdEmsmmsmmsmmsmmsmmsm+msomsomsomsomso mso mso mso msp&msp&mtt&m{t#m{t#m{t@m{tDm{tDm{u m{u#m{u#m{u#m{u#m{u+m{u8 m{uAm{uAm{uAm{uBm{uBm{uCm{uC m{uDm{uDm{uDm{vm{vm{v m{v2 m~i& m~iFm~ik m~ik m~im~io`g8o`g8 o`gAo`gEobj& olkolk olk olk olk olk&olk+ olk@olkAolkBolkBolkColkColkColkEolkEolkGolkGolkG olki olkjolklolklolklolkoolkoolko olko olkolkolkolklk@ @olkolk om~F om~F om~mom~ om~om~~~~CTHE DEVICE LEAKED DURING INJECTION OF RADIOACTIVE MATERIAL. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. DISPLAYED EXCESSIVE ARTIFACT DURING USE ON A PT (T CONDITION AND DIAGNOSIS NOT REPORTED). THE OPERATOR CHANGED THE PT CABLE WITH NO IMPROVEMENT IN THE DISPLAYED ECG. A BACKUP PT MONITOR WAS MADE AVAILABLE AND USED WITH NO OTHER PROBLEMS REPORTED. THE PT WAS DESCRIBED AS OK. THE SERVICE REP EVAL THE UNIT AND OBSERVED THAT THE PT CABLE CONNECTOR KEY WAS WORN/BROKEN AWAY. THE PT CABLE COULD BE PLUGGED IN ANY ORIENTATION. THE PT CABLE CONNECTOR WAS REPLACED. FOLLOWING THE REPAIRS, PROPER OPERATION W AS OBSERVED WAS OBSERVED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. THE TUBING SEPARATED FROM THE STOPCOCK DURING USE. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER RETURNED ONE UNUSED AND ONE USED SAMPLE FOR EVALUATION. EXAMINATION OF THE RETURNED USED UNIT REVEALED THAT THE TUBING WAS SEPARATED FROM THE STOPCOCK BECAUSE THE TUBING HAD NOT BEEN INSERTED FAR ENOUGH INTO THE TUBING PORT TO ENSURE A SECURE CONNECTION. CO'S PRODUCTION PERSONNEL WERE NOTIFIED OF THIS ISSUE. EXAMINATION OF THE RETUNRED UNUSED UNIT REVEALED THAT THE TUBI NG WAS SECURE INSIDE THE STOPCOCK AND EXCEEDED CO'S MINIMUM SPECIFICATION FOR PULL TESTING. CO'S WAS ABLE TO CONFIRM THIS ISSUE AND DETERMINE THE CAUSE. 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THE STAPLES DID NOT FORM ON THE SECOND FIRING AND THE INDIVIDUAL STAPLES HAD TO BE REMOVED FROM THE PT. NO CONSEQUENCE TO THE PT. DEVICE WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATON. AT THE COMPLETION OF THE PROCEDURE, IT WAS FOUND THAT THE TROCAR TIP HAD SHATTERED INTO MULTIPLE FRAGMENTS. MOST OF THE FRAGMENTS WERE REMOVED FROM PT'S ABDOMEN, HOWEVER, SURGEON EXPRESSED C ONCERN THAT SEVERAL PIECES MAY STILL BE PRESENT. NO CONSEQUENCE TO THE PT. DEVICE WAS USED DURING AN ABDOMINAL HYSTERECTOMY. THE CASE BEGAN AS A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BUT WAS CONVERTED TO AN OPEN PROCEDURE DUE TO ADHESIONS. 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ANTIGEN, ANTISERUM, CONTROL2866.5510-%$CZOINTER-ALPHA TRYPSIN INHIBITOR, ANTIGEN, ANTISERUM, CONTROL1866.5890G?>CZNIGA, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55103+*CZMIGA, FERRITIN, ANTIGEN, ANTISERUM, CONTROL2866.55107/.CZLIGA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2866.5510910CZKIGA, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.551080/CZJIGD, ANTIGEN, ANTISERUM, CONTROL2866.5510-%$CKHACID PHOSPHATASE, BETA GLYCEROPHOSPHATE2862.10204,+CKGRADIOIMMUNOASSAY, ACTH2862.1025#CKFPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES2862.1050@87CKEACID PHOSPHATASE, THYMOLPHTHALE INMONOPHOSPHATE2862.1020<43CKDHYDRAZONE COLORIMETRY, ALT/SGPT1862.1030,$#CKCVANILLIN PYRUVATE, ALT/SGPT1862.1030( CKBACID PHOSPHATASE, NAPHTHYL PHOSPHATE2862.10201)(CKANADH OXIDATION/NAD REDUCTION, ALT/SGPT1862.10303+*CJZACID, HYDROXYAZOBENZENE-BENZOIC, ALBUMIN2862.10355-,CJYAZO DYE, CALCIUM2862.1145CJXACID PHOSPHATASE, DISODIUM PHENYLPHOSPHATE2862.10207/.CJWBROMCRESOL PURPLE DYE-BINDING, ALBUMIN2862.10353+*CJTHYDRAZONE COLORIMETRY, ALDOLASE1862.1040,$#CJRACID PHOSPHATASE, THYMOL BLUE MONOPHOSPHATE2862.102080/CJQRADIAL IMMUNODIFFUSION, ALBUMIN2862.1035,$#CJOALPHA-NAPHTHYL PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES2862.1050IA@CJNACID PHOSPHATASE, NITROPHENYLPHOSPHATE2862.10203+*CJMRADIOIMMUNOASSAY, ALDOSTERONE2862.1045*"!CJLBETA GLYCEROPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES2862.1050F>=CJKPHENOLPHTHALEIN PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES2862.1050JBA@u9x9r4` gz&DXDBACOMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL2866.5250OGFDAZFIBRINOGEN AND SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL2864.7340G?>DAYCOMPLEMENT C5, ANTIGEN, ANTISERUM, CONTROL2866.52407/.DAXFIBRINOGEN AND SPLIT PRODUCTS, FITC, ANTIGEN, ANTISERUM, CONTROL2864.7340MEDDAWALPHA-2-AP-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL1866.5425A98DATFIBRINOGEN AND SPLIT PRODUCTS, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2864.7340SKJDASIGG (FC FRAGMENT SPECIFIC), ANTIGEN, ANTISERUM, CONTROL1866.5530D<;DARFIBRINOGEN AND SPLIT PRODUCTS, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2864.7340RJIDAQIGG (FD FRAGMENT SPECIFIC), ANTIGEN, ANTISERUM, CONTROL1866.5540D<;DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL2864.7320NFEDAOIGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL2866.5550A98DANFIBRINOPEPTIDE A, ANTIGEN, ANTISERUM, CONTROL2866.5350:21DAMHEMOGLOBIN, CHAIN SPECIFIC, ANTIGEN, ANTISERUM, CONTROL2866.5470D<;DALFRACTION IV-5, ANTIGEN, ANTISERUM, CONTROL1866.53607/.DAKCOMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL2866.524080/DAJFREE SECRETORY COMPONENT, ANTIGEN, ANTISERUM, CONTROL2866.5380B:9DAICOMPLEMENT C1R, ANTIGEN, ANTISERUM, CONTROL2866.524080/DAHGAMMA GLOBULIN, ANTIGEN, ANTISERUM, CONTROL2866.551080/DAGCOMPLEMENT C8, ANTIGEN, ANTISERUM, CONTROL2866.52407/.DAFGAMMA GLOBULIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5510>65DAECOMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL2866.52407/.DADHAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL2866.54605-,DACCOMPLEMENT C3B ACTIVATOR, ANTIGEN, ANTISERUM, CONTROL2866.5260B:9DABHAPTOGLOBIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5460;32DAAIGG, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2866.5510910CZZHAPTOGLOBIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5460@87CZYCOMPLEMENT C1S, ANTIGEN, ANTISERUM, CONTROL2866.524080/CZXHEMOPEXIN, ANTIGEN, ANTISERUM, CONTROL2866.54903+*;["Oa.t@DD<U<ȉSTXDNHRESINS, ION-EXCHANGE, LIQUID CHROMATDDHCARBONIC ANHYDRASE B, ANTIGEN, ANTISERUM, CONTROL1866.5200>65DDGTRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL2866.58805-,DDFPROTHROMBIN, ANTIGEN, ANTISERUM, CONTROL1866.57355-,DDECARBONIC ANHYDRASE C, ANTIGEN, ANTISERUM, CONTROL1866.5200>65DDDTRANSFERRIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5880@87DDCTHYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL2866.58707/.DDBCERULOPLASMIN, ANTIGEN, ANTISERUM, CONTROL2866.52107/.DCYCERULOPLASMIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5210=54DCTCERULOPLASMIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5210B:9DCOALPHA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL1866.540080/DCNSYSTEM, TEST, C-REACTIVE PROTEIN2866.5270-%$DCKC-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL2866.5270@87DCJBETA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL1866.51607/.DCHSYSTEM, TEST, C-REACTIVE PROTEIN, RHODAMINE2866.527080/DCFALBUMIN, ANTIGEN, ANTISERUM, CONTROL2866.50401)(DCEFAB, ANTIGEN, ANTISERUM, CONTROL1866.5520-%$DCBFAB, FITC, ANTIGEN, ANTISERUM, CONTROL1866.55203+*DBYFAB, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL1866.552080/DBTFACTOR XIII A, S, ANTIGEN, ANTISERUM, CONTROL1866.5330:21DBNFC, ANTIGEN, ANTISERUM, CONTROL1866.5530,$#DBMANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL2866.5090UMLDBLMULTIPLE AUTOANTIBODIES, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL2866.5660RJIDBKFC, FITC, ANTIGEN, ANTISERUM, CONTROL1866.55302*)DBJANTIPARIETAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL2866.5110PHGDBICOMPLEMENT C4, ANTIGEN, ANTISERUM, CONTROL2866.52407/.DBHFC, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL1866.55307/.DBFFERRITIN, ANTIGEN, ANTISERUM, CONTROL2866.53402*)DBEANTISMOOTH MUSCLE ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL2866.5120UMLDBCALPHA 2, 2N-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL1866.5425B:9z2^QKi-f%\ \J"CVDQFACTUATOR, SYDESLAMBDA, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55506.-DERALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL2866.5580=54DEPLAMBDA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2866.5550<43DEOKAPPA, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55505-,DENALPHA-1-T-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL1866.5420@87DEMALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL2866.5130=54DELLIPOPROTEIN X, ANTIGEN, ANTISERUM, CONTROL1866.55907/.DEKKAPPA, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5550:21DEJALPHA-2-GLYCOPROTEINS, ANTIGEN, ANTISERUM, CONTROL1866.5425?76DEIALPHA-1-ANTITRYPSIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5130C;:DEHLAMBDA, ANTIGEN, ANTISERUM, CONTROL2866.55500('DEGLACTOFERRIN, ANTIGEN, ANTISERUM, CONTROL1866.55705-,DEFALPHA-2-HS-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL1866.5425A98DECINTER-ALPHA TRYPSIN INHIBITOR, FITC, ANTIGEN, ANTISERUM, CONTROL1866.5890MEDDEBALPHA-2-MACROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL2866.5620?76DEAMYOGLOBIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5680910DDZALBUMIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.50407/.DDYALPHA-2-MACROGLOBULIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5620E=<DDXPLASMINOGEN, ANTIGEN, ANTISERUM, CONTROL1866.57155-,DDTALPHA-2-MACROGLOBULIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5620JBADDSPREALBUMIN, FITC, ANTIGEN, ANTISERUM, CONTROL1866.5060:21DDRMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL2866.56803+*DDQANTIGEN, ANTISERUM, CONTROL, ANTITHROMBIN III2864.7060:21DDOMYOGLOBIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5680>65DDNBETA-2-GLYCOPROTEIN I, ANTIGEN, ANTISERUM, CONTROL1866.5430?76DDLTHYROGLOBULIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5870B:9DDKBETA-2-GLYCOPROTEIN III, ANTIGEN, ANTISERUM, CONTROL1866.5440A98DDJTHYROGLOBULIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5870=54DDITRANSFERRIN, FITC, ANTIGEN, ANTISERUM, CONTROL2866.5880;327@r)\&Tc)n-}>}"IMDBHFC, RDGIBREAST MILK, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL1866.5170@87DGHIGD, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2866.5510910DGGIGD, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55103+*DGEIGD, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.551080/DGDIGG, FERRITIN, ANTIGEN, ANTISERUM, CONTROL2866.55107/.DGCIGE, ANTIGEN, ANTISERUM, CONTROL2866.5510-%$DGBSEMINAL FLUID, ANTIGEN, ANTISERUM, CONTROL1866.58007/.DGACOHN FRACTION II, ANTIGEN, ANTISERUM, CONTROL1866.5220:21DFZIGG (GAMMA CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL2866.5510D<;DFXSPERM, FITC, ANTIGEN, ANTISERUM, CONTROL1866.58005-,DFTIGM, ANTIGEN, ANTISERUM, CONTROL2866.5550-%$DFSIGM, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55503+*DFQSPERM, ANTIGEN, ANTISERUM, CONTROL1866.5800/'&DFOIGG, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.551080/DFMIGE, FERRITIN, ANTIGEN, ANTISERUM, CONTROL2866.55107/.DFLIGM, FERRITIN, ANTIGEN, ANTISERUM, CONTROL2866.55507/.DFKIGG (FAB FRAGMENT SPECIFIC), ANTIGEN, ANTISERUM, CONTROL1866.5520E=<DFJALBUMIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5040<43DFITOTAL SPINAL-FLUID, ANTIGEN, ANTISERUM, CONTROL1866.5860<43DFHKAPPA, ANTIGEN, ANTISERUM, CONTROL2866.5550/'&DFGLAMBDA, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5550;32DFFALPHA-1-ANTICHYMOTRYPSIN, ANTIGEN, ANTISERUM, CONTROL2866.5080B:9DFDKAPPA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2866.5550;32DFCLIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL2866.5600B:9DFBALPHA-1-ANTITRYPSIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.5130H@?DEZIGM, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.555080/DEYIGM, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2866.5550910DEXALPHA-1-B-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL1866.5420@87DEWIGG, ANTIGEN, ANTISERUM, CONTROL2866.5510-%$DETLACTIC DEHYDROGENASE, ANTIGEN, ANTISERUM, CONTROL1866.5560>65&!MUZ]$RXU5r}XDEEAGCEPHALOMETER22872.18DIMGAS CHROMATOGRAPHY, SALICYLATE2##"DILRADIOIMMUNOASSAY, PRIMIDONE2862.3680( DIKTHIN LAYER CHROMATOGRAPHY, QUININE1862.3750/'&DIJLEAD, DELTA AMINO LEVULINIC ACID2862.3550-%$DIICOLUMNS, GLC1862.2250DIHCOLORIMETRY, CHOLINESTERASE1862.3240( DIGCHOLINESTERASE TEST PAPER1862.3240&DIFDRUG MIXTURE CONTROL MATERIALS1862.3280+#"DIEHEAVY METALS CONTROL MATERIALS1862.3280+#"DIDBACILLUS SUBTLIS MICROBIOLOGY ASSAY, TOBRAMYCIN2862.3900<43DICALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD2862.3040NFEDHYNG4M(A), ANTIGEN, ANTISERUM, CONTROL1866.50651)(DHXSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN3866.60103+*DHRSYSTEM, TEST, RHEUMATOID FACTOR2866.5775,$#DHQNG3M(G), ANTIGEN, ANTISERUM, CONTROL1866.50651)(DHNANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL2866.5100OGFDHLPROTEIN, COMPLEMENT, ANTIGEN, ANTISERUM, CONTROL1866.4100=54DHING3M(BO), ANTIGEN, ANTISERUM, CONTROL1866.50652*)DHFD/KM-1, ANTIGEN, ANTISERUM, CONTROL1866.50650('DHCSYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS2866.58207/.DHBSYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL2866.5750C;:DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN2862.11557/.DGXNG1M(A), ANTIGEN, ANTISERUM, CONTROL1866.50651)(DGWSYSTEM, TEST, HYPERSENSITIVITY PNEUMONITIS2866.55007/.DGRWHOLE HUMAN SERUM, ANTIGEN, ANTISERUM, CONTROL1866.5700;32DGQWHOLE BLOOD PLASMA, ANTIGEN, ANTISERUM, CONTROL1866.5700<43DGPIGE, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55103+*DGOIGE, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL2866.5510910DGNBREAST MILK, FITC, ANTIGEN, ANTISERUM, CONTROL1866.5170;32DGMBREAST MILK, ANTIGEN, ANTISERUM, CONTROL1866.51705-,DGLIGE, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL2866.551080/DGKIGG, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55103+*DGJCOLOSTRUM, ANTIGEN, ANTISERUM, CONTROL1866.52303+*A%Q\"]pA[( _,yJDESLAMBDA, FITC, ANTIGEN, ANTISERUM, CONTROL2866.55506.-DKCALCOHOL CONTROL MATERIALS1862.3280&DKBCALIBRATORS, DRUG MIXTURE2862.3200&DKAANTISERUM, DIGOXIN2862.3320DJZDEVICES, BREATH TRAPPING, ALCOHOL1862.3050.&%DJYION-EXCHANGE CHROMATOGRAPHY1862.2230( DJXRADIOIMMUNOASSAY, ETHOSUXIMIDE2862.3380+#"DJWTEST REAGENTS FOR CHLORAL HYDRATE2&&%DJSU.V. LIGHT, TLC1862.2270DJRENZYME IMMUNOASSAY, METHADONE2862.3620*"!DJQTEST REAGENTS FOR PHENOTHIAZINE2862.3670,$#DJPRADIOIMMUNOASSAY, AMPHETAMINE2862.3100*"!DJOINDICATOR, CELLULOSE FLUORESCENT, TLC1862.22702*)DJNMERCURY DITHIAZONE, COLORIMETRY, BARBITURATE2862.3150910DJMTEST REAGENTS, ZINC2DJLFREE RADICAL ASSAY, AMPHETAMINE2862.3100,$#DJKDIGITOXIN CONTROL SERUM, RIA1862.3280)! DJJFLUOROMETRY, MORPHINE2862.3640"DJIANTISERUM, GENTAMICIN2862.3450"DJHGAS CHROMATOGRAPHY, PHENOBARBITAL2862.3660.&%DJGENZYME IMMUNOASSAY, OPIATES2862.3650( DJFGAS CHROMATOGRAPHY, OPIATES2862.3650( DJETHIN LAYER CHROMATOGRAPHY, SALICYLATE2**)DJDENZYME IMMUNOASSAY, PRIMIDONE2862.3680*"!DJCTHIN LAYER CHROMATOGRAPHY, METAMPHETAMINE2862.36106.-DJBRADIOIMMUNOASSAY, GENTAMICIN (125-I), SECOND ANTIBODY SEP.2862.3450G?>DJACOLUMN SUPPORTS, GLC1862.2250!DIZDELAYED ANALYSIS, ALCOHOL2862.3040&DIYGAS CHROMATOGRAPHY, ETHOSUXIMIDE2862.3380-%$DIXTHIN LAYER CHROMATOGRAPHY, PHENOBARBITAL2862.36605-,DIWHEMAGGLUTINATION INHIBITION, METHADONE2862.36203+*DITTHIN LAYER CHROMATOGRAPHY, AMPHETAMINE2862.31003+*DISENZYME IMMUNOASSAY, BARBITURATE2862.3150,$#DIRFREE RADICAL ASSAY, COCAINE2862.3250( DIQRADIOIMMUNOASSAY, MORPHINE (3-H), GOAT ANTIBODY AMMONIUM SULFATE SEP.2862.3640RJIDIPENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN2862.33502*)DIOENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES2862.3250@87DINGAS CHROMATOGRAPHY, COCAINE2862.3250( 1%Xm:C sB!j;k1{NDIMGAS CHROMATOGRADMBGAS CHROMATOGRAPHY, METHADONE2862.3620*"!DLZENZYME IMMUNOASSAY, PHENOBARBITAL2862.3660.&%DLYPLATE, ALUMINA, TLC1862.2270 DLXHEMAGGLUTINATION INHIBITION, BARBITURATE2862.31505-,DLTHEMAGGLUTINATION, OPIATES2862.3650&DLSGAS CHROMATOGRAPH, ALCOHOL (DEDICATED INSTRUMENTS)2862.3040?76DLRHEMAGGLUTINATION INHIBITION, MORPHINE2862.36402*)DLPRADIOIMMUNOASSAY, DIPHENYLHYDANTOIN2862.33500('DLOINDICATOR, SILICA GEL FLUORESCENT, TLC1862.22703+*DLNHEMAGGLUTINATION, COCAINE METABOLITES (BENZOYLECGNONINE)2862.3250E=<DLJCALIBRATORS, DRUG SPECIFIC2862.3200'DLIACETYLCHOLINE CHLORIDE, SPECIFIC REAGENT FOR PSEUDO CHOLINESTERASE1862.3240OGFDLHGAS CHROMATOGRAPHY, ALCOHOL2862.3040( DLGCOATING, LIQUID, GLC1862.2250!DLFENZYME IMMUNOASSAY, ETHOSUXIMIDE2862.3380-%$DLEREAGENTS, TEST, BROMIDES2DLDTHIN LAYER CHROMATOGRAPHY, CODEINE2862.3270/'&DLCATOMIZER, TLC1862.2270DLBRADIOIMMUNOASSAY, LSD (125-I)2862.3580*"!DLATEST REAGENTS FOR METHYL ALCOHOL2%%$DKZENZYME IMMUNOASSAY, AMPHETAMINE2862.3100,$#DKYINDICATOR, ALUMINA FLUORESCENT, TLC1862.22700('DKXTHIN LAYER CHROMATOGRAPHY, BARBITURATE2862.31503+*DKWTEST REAGENTS FOR SULPHANIMIDE DERIVATIVES1862.38507/.DKTFREE RADICAL ASSAY, OPIATES2862.3650( DKSPLATE, SILICA GEL, TLC1862.2270#DKRTHIN LAYER CHROMATOGRAPHY, METHADONE2862.36201)(DKQANTISERUM, DIGITOXIN2862.3300!DKPRADIOIMMUNOASSAY, PHENOBARBITAL2862.3660,$#DKOADSORBENTS, ION-EXCHANGE1862.2230%DKNRADIOIMMUNOASSAY, BARBITURATE2862.3150*"!DKKTANKS, DEVELOPING, TLC1862.2270#DKJCOLORIMETRY, SALICYLATE2862.3830$DKHGAS CHROMATOGRAPHY, DIPHENYLHYDANTOIN2862.33502*)DKGPLATE, CELLULOSE, TLC1862.2270"DKEREAGENTS, TEST, TETRAHYDROCANNABINOL2862.38701)(DKDBACILLUS SUBTLIS, MICROBIOLOGICAL ASSAY, GENTAMICIN2862.3450@875 b/{Mf9 Xf'cc p$I$I$I$I$I$I$I$I$I$IDEECRSETTER, BDNTLIQUID CHROMATOGRAPHY, METHADONE2862.3620-%$DNSRADIOIMMUNOASSAY, DIGOXIN (125-I), RABBIT ANTIBODY, DOUBLE LABEL SEP.2862.3320RJIDNQRADIOIMMUNOASSAY, DIGOXIN (3-H), RABBIT ANTIBODY, COATED TUBES SEP.2862.3320PHGDNPTHIN LAYER CHROMATOGRAPHY, ETHOSUXIMIDE2862.33804,+DNOHEMAGGLUTINATION INHIBITION, GENTAMICIN2862.34504,+DNNCALIBRATORS, ETHYL ALCOHOL2862.3200'DNLRADIOIMMUNOASSAY, DIGOXIN (125-I), RABBIT ANTIBODY, SECOND ANTIBODY SEP.2862.3320UMLDNKTHIN LAYER CHROMATOGRAPHY, MORPHINE2862.36400('DNJRADIOIMMUNOASSAY, DIGOXIN (125-I), GOAT ANTIBODY, 2ND ANTIBODY SEP.2862.3320PHGDNILIQUID CHROMATOGRAPHY, AMPHETAMINE2862.3100/'&DNHRESINS, ION-EXCHANGE, LIQUID CHROMATOGRAPHY1862.226080/DNGFREE RADICAL, BENZOYLECGNONINE2862.3250+#"DNFLIQUID CHROMATOGRAPHY, ETHOSUXIMIDE2862.33800('DNEATOMIC ABSORPTION, ANTIMONY1862.3110( DNDRADIOIMMUNOASSAY, DIGITOXIN (125-I), RABBIT ANTIBODY, SOLID PHASE SEP.2862.3300SKJDNCSTRIP, PAPER, SALICYLATE2862.3830%DNARADIOIMMUNOASSAY, MORPHINE-BARBITURATE (125-I), GOAT ANTIBODY2862.3640JBADMZLIQUID CHROMATOGRAPHY, ADSORBENT1862.2260-%$DMYGAS CHROMATOGRAPHY, MORPHINE2862.3640)! 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GGZOXYHEMOGLOBIN2864.7500GGYPIPETTE, DILUTING1864.6160GGXPIPETTE, SAHLI1864.6160GGWTEST, TIME, PARTIAL THROMBOPLASTIN2864.7925/'&GGTASSAY, ERYTHROPOIETIN3864.7250"GGQTEST, PROTHROMBIN CONSUMPTION2864.7720*"!GGPTEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY2864.7290A98GGOREAGENT, THROMBOPLASTIN AND CONTROL2864.79250('GGNPLASMA, COAGULATION CONTROL2864.5425( GGMCONTROL, HEMOGLOBIN2864.8625 GGLCONTROL, WHITE-CELL2864.8625 GGKPRODUCTS, RED-CELL LYSING PRODUCTS1864.8540/'&GGJFLUID, DILUTING, WHITE-CELL1864.8200( 'a<L~TZ0b%jCZ+YGMGANTIGEN, LATEX AGGLUTINATION, COCCIDIOIDES IMMITIS2866.3135?76GMEANTISERA, FLUORESCENT, CRYPTOCOCCUS NEOFORMANS2866.3165;32GMDANTISERA, LATEX AGGLUTINATION, CRYPTOCOCCUS NEOFORMANS2866.3165C;:GMBLIGHT, WOOD'S, FLUORESCENCE1866.2600( GMAANTISERA, FLUORESCENT, SPOROTHRIX SCHENEKII1866.368080/GLZANTIGENS, IF, TOXOPLASMA GONDII2866.3780,$#GLYOXIMETER TO MEASURE HEMOGLOBIN2864.7500+#"GLQMIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES2864.8625>65GLKCONTROL, HEMATOCRIT2864.8625 GLGPLATELET COUNTING, MANUAL1864.6160&GLEMIXER, BLOOD TUBE1862.2050GKZCOUNTER, DIFFERENTIAL CELL2864.5220'GKXINSTRUMENT, AUTOMATED PLATELET COUNTING2864.52004,+GKWAGGREGOMETER, PLATELET, THROMBOKINETOGRAM2864.66756.-GKTSEPARATOR, AUTOMATED, BLOOD CELL3864.9245-%$GKRSYSTEM, HEMOGLOBIN, AUTOMATED2864.5620*"!GKQTEST, THROMBOPLASTIN GENERATION1864.7900,$#GKPINSTRUMENT, COAGULATION, AUTOMATED2864.5400/'&GKNTIMER, CLOT, AUTOMATED2864.5400#GKMHAND-TALLY, DIFFERENTIAL1864.6160%GKLCOUNTER, CELL, AUTOMATED (PARTICLE COUNTER)2864.520080/GKKCYANOMETHEMOGLOBIN2864.7500GKJSPINNER, SLIDE, AUTOMATED1864.5850&GKHAPPARATUS, AUTOMATED BLOOD CELL DILUTING1864.52405-,GKGCENTRIFUGE, HEMATOCRIT2864.6400#GKFINSTRUMENT, HEMATOCRIT, AUTOMATED2864.5600.&%GKEOSMOTIC FRAGILITY TESTING1864.6600&GKBDEVICE, AUTOMATED SEDIMENTATION RATE1864.58001)(GKAABNORMAL HEMOGLOBIN QUANTITATION2864.7415-%$GJZCYANOMETHEMOGLOBIN REAGENT AND STANDARD SOLUTION2864.7500=54GJWPIPETTE, PASTEUR1864.6160GJTPLASMA, COAGULATION FACTOR DEFICIENT2864.72901)(GJSTEST, TIME, PROTHROMBIN2864.7750$GJRCONTROL, RED-CELL2864.8625GJPCONTROL, PLATELET2864.8625GJNFLUID, DILUTING, RED-CELL1864.8200&GJLROMANOWSKY STAINS1864.1850GJJSTAINS, HEINZ BODY1864.1850GJHSTAIN, RETICULOCYTE1864.1850  |CTKu/5 Sl%VnGNOANTISERA, CF, COXSACKIEVIRUS A 1-24, B 1-61866.31457/.GNNANTISERA, NEUTRALIZATION, COXSACKIEVIRUS A 1-24, B 1-61866.3145C;:GNMANTISERA, FLUORESCENT, COXSACKIEVIRUS A 1-24, B 1-61866.3145@87GNLANTIGENS, CF (INCLUDING CF CONTROL), ECHOVIRUS 1-341866.3205@87GNKANTISERA, CF, ECHOVIRUS 1-341866.3205)! GNJANTIGENS, HA, ECHOVIRUS 1-341866.3205)! GNIANTISERA, NEUTRALIZATION, ECHOVIRUS 1-341866.32055-,GNHANTIGEN, FLUORESCENT ANTIBODY TEST, SCHISTOSOMA MANSONI1866.3600D<;GNGANTIGENS, CF (INCLUDING CF CONTROL), COXSACKIEVIRUS A 1-24, B 1-61866.3145NFEGNFANTIGEN, CF, T. CRUZI1866.3870"GNEANTIGEN, LATEX AGGLUTINATION, T. CRUZI1866.38703+*GNDANTIGEN, IHA, T. CRUZI1866.3870#GNCANTIGENS, FEBRILE, SLIDE AND TUBE, ALL GROUPS, SALMONELLA SPP.2866.3550KCBGNBANTISERA, ALL TYPES, SHIGELLA SPP.2866.3660/'&GNAANTISERA, ALL TYPES, ESCHERICHIA COLI1866.32552*)GMZANTIGENS, ALL TYPES, ESCHERICHIA COLI1866.32552*)GMYANTISERA, FLUORESCENT, ALL TYPES, ESCHERICHIA COLI1866.3255?76GMXANTISERA, FLUORESCENT ANTIBODY FOR FTA-ABS TEST2866.3830<43GMWTEST, SORBENT, FTA-ABS2866.3830#GMTANTIGENS, HA, TREPONEMA PALLIDUM2866.3830-%$GMSANTI-HUMAN GLOBULIN, FTA-ABS TEST2866.3830.&%GMRSERA, REACTIVE AND NON-SPECIFIC CONTROL, FTA-ABS TEST2866.3830B:9GMQANTIGENS, NONTREPONEMAL, ALL2866.3820)! GMPANTISERA, CONTROL FOR NONTREPONEMAL TESTS2866.38206.-GMOANTIGEN, LATEX AGGLUTINATION, ENTAMOEBA HISTOLYTICA & REL. SPP.2866.3220LDCGMNANTIGENS, CF, TOXOPLASMA GONDII2866.3780,$#GMMANTIGENS, IHA, TOXOPLASMA GONDII2866.3780-%$GMLANTISERA, FLUORESCENT, HISTOPLASMA CAPSULATUM2866.3320:21GMKANTISERUM, POSITIVE CONTROL, HISTOPLASMA CAPSULATUM2866.3320@87GMJANTIGENS, HISTOPLASMA CAPSULATUM, ALL2866.33202*)GMIANTIGEN, CF AND/OR ID, COCCIDIOIDES IMMITIS2866.313580/GMHANTISERUM, POSITIVE CONTROL, COCCIDIOIDES IMMITIS2866.3135>65 <y)9Jf$}4_6imY9mN.EGPDANTIGEN, INDIRECT FLUORESCENT ANTIBODY TEST, ECHINOCOCCUS GRANULOSUS1866.3200QIHGOZANTISERA, FLUORESCENT, B. PERTUSSIS1866.30650('GOYANTISERA, AGGLUTINATING, B. PERTUSSIS, ALL1866.30657/.GOXANTIGEN, B. PERTUSSIS1866.3065"GOWANTISERA, AGGLUTINATING, B. PARAPERTUSSIS1866.30656.-GOTANTIGEN, B. PARAPERTUSSIS1866.3065&GOSANTISERUM, FLUORESCENT, C. DIPHTHERIAE1866.31403+*GOPANTISERA, C. 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GOFANTISERA, NEUTRALIZATION, POLIOVIRUS 1-31866.34055-,GOEANTISERA, FLUORESCENT, POLIOVIRUS 1-31866.34052*)GODANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-331866.3020A98GOCANTISERA, HAI, ADENOVIRUS 1-331866.3020+#"GOBANTIGENS, HA (INCLUDING HA CONTROL), ADENOVIRUS 1-331866.3020A98GOAANTISERA, CF, ADENOVIRUS 1-331866.3020*"!GNZANTISERA, NEUTRALIZATION, ADENOVIRUS 1-331866.30206.-GNYANTISERA, FLUORESCENT, ADENOVIRUS 1-331866.30203+*GNXANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C1866.3330IA@GNWANTISERA, CF, INFLUENZA VIRUS A, B, C1866.33302*)GNTANTIGENS, HA (INCLUDING HA CONTROL), INFLUENZA VIRUS A, B, C1866.3330IA@GNSANTISERA, HAI, INFLUENZA VIRUS A, B, C1866.33303+*GNRANTISERA, NEUTRALIZATION, INFLUENZA VIRUS A, B, C1866.3330>65GNQANTIGEN, CF (INCLUDING CF CONTROL), EPSTEIN-BARR VIRUS1866.3235C;:GNPANTISERUM, CF, EPSTEIN-BARR VIRUS1866.3235.&% <uH}IyAZv,_TGGQMANTISERA, NEUTRALIZATION, HERPESVIRUS HOMINIS3866.3305:21GQLANTISERA, FLUORESCENT, HERPESVIRUS HOMINIS 1,23866.3305;32GQKANTIGEN, CF, LYMPHOCYTIC CHORIOMENINGITIS VIRUS1866.3360<43GQJANTISERUM, CF, LYMPHOCYTIC CHORIOMENINGITIS VIRUS1866.3360>65GQIANTISERUM, CF, CYTOMEGALOVIRUS2866.3175+#"GQHANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS2866.3175@87GQGANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS1866.3480MEDGQFANTISERUM, NEUTRALIZATION, RESPIRATORY SYNCYTIAL VIRUS1866.3480C;:GQEANTISERA, NEUTRALIZATION, ALL TYPES, RHINOVIRUS1866.3490<43GQDANTIGENS, CF (INCLUDING CF CONTROL), EQUINE ENCEPHALITIS VIRUS, EEE, WEE1866.3240UMLGQCANTISERA, CF, EQUINE ENCEPHALITIS VIRUS, EEE, WEE1866.3240>65GQBANTIGENS, CF (INCLUDING CF CONTROL), REOVIRUS 1-31866.3470>65GQAANTIGENS, HA (INCLUDING HA CONTROL), REOVIRUS 1-31866.3470>65GPZANTISERA, CF, REOVIRUS 1-31866.3470'GPYANTISERA, HAI, REOVIRUS 1-31866.3470( GPXANTISERA, NEUTRALIZION, REOVIRUS 1-31866.34701)(GPWANTIGEN, CF, PSITTACOSIS (CHLAMYDIA GROUP)1866.31207/.GPTANTISERUM, CF, PSITTACOSIS (CHLAMYDIA GROUP)1866.3120910GPSANTIGEN, CF, Q FEVER1866.3500!GPRANTISERUM, CF, Q FEVER1866.3500#GPQANTIGEN, CF, SPOTTED FEVER GROUP1866.3500-%$GPPANTISERUM, ROCKY MOUNTAIN SPOTTED FEVER1866.35004,+GPOANTIGEN, CF, TYPHUS FEVER GROUP1866.3500,$#GPNANTISERUM, TYPHUS FEVER1866.3500$GPMANTISERUM, MURINE TYPHUS FEVER1866.3500+#"GPKANTISERUM, RICKETTSIALPOX1866.3500&GPJANTISERUM, FLUORESCENT, Q FEVER1866.3500,$#GPIANTIGEN, BENTONITE FLOCCULATION, TRICHINELLA SPIRALIS1866.3850B:9GPHANTISERUM, BENTONITE FLOCCULATION, TRICHINELLA SPIRALIS1866.3850D<;GPGANTIGEN, LATEX AGGLUTINATION, TRICHINELLA SPIRALIS1866.3850?76GPFANTIGEN, AGGLUTINATING, ECHINOCOCCUS SPP.1866.32006.-GPEANTISERA, POSITIVE CONTROL, ECHINOCOCCUS SPP.1866.3200:21!x3Y a'PSh#j9a}GSBANTIGENS, CF, ALL, MYCOPLASMA SPP.1866.3375/'&GSAANTISERA, ALL MYCOPLASMA SPP.1866.3375*"!GRZANTISERA, FLUORESCENT, ALL, MYCOPLASMA SPP.1866.337580/GRYANTIGENS, ALL, LEPTOSPIRA SPP.2866.3350+#"GRXANTISERA, ALL LEPTOSPIRA SPP.2866.3350*"!GRWANTISERA, ALL FLUORESCENT, LEPTOSPIRA SPP.2866.33507/.GRTANTISERUM, FLUORESCENT, MYCOBACTERIUM TUBERCULOSIS1866.3370?76GRPANTISERA, ALL TYPES, H. INFLUENZA2866.3300.&%GROANTISERA, FLUORESCENT, ALL TYPES, HEMOPHILUS SPP.2866.3300>65GRMANTISERA, ALL GROUPS, SALMONELLA SPP.2866.35502*)GRLANTIGENS, ALL GROUPS, SALMONELLA SPP.2866.35502*)GRKANTISERA, FLUORESCENT, ECHOVIRUS 1-341866.32052*)GRJANTIGEN, CF, (INCLUDING CF CONTROL), RUBEOLA1866.3520910GRIANTISERUM, NEUTRALIZATION, RUBEOLA1866.3520/'&GRHANTIGEN, HA (INCLUDING HA CONTROL), RUBEOLA1866.352080/GRGANTISERUM, HAI, RUBEOLA1866.3520$GRFANTISERUM, CF, RUBEOLA1866.3520#GREANTISERUM, FLUORESCENT, RUBEOLA1866.3520,$#GRDANTISERUM, HAI, MUMPS VIRUS1866.3380( GRCANTIGEN, CF (INCLUDING CF CONTROL), MUMPS VIRUS1866.3380<43GRBANTISERUM, CF, MUMPS VIRUS1866.3380'GRAANTISERUM, FLUORESCENT, MUMPS VIRUS1866.33800('GQZANTISERUM, NEUTRALIZATION, MUMPS VIRUS1866.33803+*GQYANTIGEN, HA (INCLUDING HA CONTROL), MUMPS VIRUS1866.3380<43GQXANTISERUM, CF, VARICELLA-ZOSTER2866.3900,$#GQWANTIGEN, CF, (INCLUDING CF CONTROL), VARICELLA-ZOSTER2866.3900B:9GQTANTISERA, CF, PARAINFLUENZA VIRUS 1-41866.34002*)GQSANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-41866.3400IA@GQRANTIGENS, HA (INCLUDING HA CONTROL), PARAINFLUENZA VIRUS 1-41866.3400IA@GQQANTISERA, HAI, PARAINFLUENZA VIRUS 1-41866.34003+*GQPANTISERA, NEUTRALIZATION, PARAINFLUENZA VIRUS 1-41866.3400>65GQOANTISERA, CF, HERPESVIRUS HOMINIS 1,23866.33052*)GQNANTIGEN, CF (INCLUDING CF CONTROL), HERPESVIRUS HOMINIS 1,23866.3305H@?}Dj(w%e"a`mLTGTJANTISERA, ALL GROUPS, N. MENINGITIDIS2866.33902*)GTIANTISERA, FLUORESCENT, ALL GROUPS, N. MENINGITIDIS2866.3390?76GTHANTISERUM, FLUORESCENT (DIRECT TEST), ALL GROUPS, N. 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