Description of Event or Problem · 1
RPTR SENT FAX DETAILING TWO INCIDENTS WITH LIFEPAK 500 AED DATED 10/19/99, AN UPDATE ADVISORY FROM HIS DEPT DATED 10/20/99, AND 10/19/99 LETTER FROM MFR, MEDTRONIC. STATE FIRE MARSHAL SAFETY BULLETIN. 10/19/99. TO: FIRE CHIEFS, LAW ENFORCEMENT, EMERGENCY SERVICES PERSONNEL. SUBJECT: LIFEPAK 500 AED. PRODUCT SAFETY ADVISORY: EXPLOSION OCCURS IN AUTOMATIC EXTERNAL DEFIBRILLATORS - "THIS NOTICE IS TO ADVISE YOU OF POTENTIAL SAFETY HAZARDS INVOLVING LIFEPAK 500 AED, WITH LITHIUM NON-RECHARGEABLE BATTERY PACKS, MANUFACTURED BY MEDTRONIC PHYSIO-CONTROL. ON TWO SEPARATE OCCASIONS, LIFEPAK 500 AED'S WERE INVOLVED IN AN INTERNAL EXPLOSION, RESULTING IN A SMALL FIRE IN THE UNIT. THE FIRST OCCURRENCE INVOLVED THE UNIT EXPLODING DURING A ROUTINE CHECK, RESULTING IN A SMALL FIRE AND INJURY TO TWO FIRE PERSONNEL. INJURIES WERE MINOR, WITH PERSONNEL STILL BEING MONITORED FOR RESPIRATORY PROBLEMS. (MODEL LIFEPAK 500, PN 3005400-300). THE OTHER INCIDENT OCCURRED WHILE THE UNIT WAS STORED IN A PARKED VEHICLE. THE UNIT APPARENTLY EXPLODED, CAUSING MINOR FIRE DAMAGE TO THE CARPET. (MODEL LIFEPAK 500, PN 3005400-320). TO DATE, THE ONLY COMMON FACTOR BETWEEN THE TWO INCIDENTS IS THAT BOTH UNITS WERE IN THE SELF-DIAGNOSTIC MODE WHEN THE EXPLOSIONS OCCURRED. INVESTIGATION INTO THIS MATTER IS STILL ON-GOING. REPRESENTATIVES OF MEDTRONIC PHYSIO-CONTROL ARE CURRENTLY INVESTIGATING EACH INCIDENT AND THE PRODUCT INVOLVED. UPDATES TO THIS SITUATION WILL BE FORWARDED AS MORE INFO IS RECEIVED OR DEVELOPED. ALL FIRE SVC, LAW ENFORCEMENT PERSONNEL AND OTHER USERS OF AED EQUIPMENT SHOULD BE ADVISED OF THIS POTENTIAL SAFETY HAZARD. SAFETY BULLETIN DATE: 10/20/99. SUBJECT: UPDATE ON LIFEPAK 500 AED. PRODUCT SAFETY ADVISORY - "THIS NOTICE IS TO SERVE AS AN UPDATE TO THIS DIVISION'S PREVIOUS SAFETY ADVISORY DEALING WITH EXPLOSIONS IN THE ABOVE NAMED PRODUCT MANUFACTURED BY MEDTRONIC PHYSIO-CONTROL CORP. THE STATE FIRE MARSHAL'S OFFICE HAS BEEN IN CONTACT WITH NUMEROUS AGENCIES IN AN ATTEMPT TO DEVELOP ALL INFO POSSIBLE TO RELAY IT TO THE APPROPRIATE AGENCIES. DURING THIS INVESTIGATION IT HAS COME TO OUR ATTENTION THAT A POSSIBLE "PANIC" CONDITION IS DEVELOPING DUE TO INFO SPREADING FROM UNCONFIRMED AND POSSIBLY UNRELIABLE SOURCES (I.E., THE INTERNET). THE STATE FIRE MARSHAL'S OFFICE HAS NOT AS OF YET MADE ANY DETERMINATIONS OR RECOMMENDATIONS AS TO THE CONTINUED USE OF THE ABOVE PRODUCTS WITHIN THE STATE OF FLORIDA. WE ARE CURRENTLY AWAITING THE RESULTS OF TESTING BEING CONDUCTED BY MEDTRONIC PHYSIO-CONTROL CORP AND THEIR RELATED SUPPLIERS. MEDTRONIC PHYSIO-CONTROL HAS BEEN COOPERATING WITH THE STATE FIRE MARSHAL'S OFFICE IN THIS INVESTIGATION AND HAS PLEDGED THEIR CONTINUED COOPERATION. THEY ADVISED THAT THE INCIDENCE OF ANY PROBLEMS WITH THEIR PRODUCTS WORLDWIDE HAS BEEN EXTREMELY LOW BUT UNDERSTAND THAT ANY PROBLEMS LIKE THOSE PREVIOUSLY MENTIONED ARE CAUSE FOR CONCERN WHERE LIVES & SAFETY ARE AT STAKE. THEY HAVE ASKED THAT WE INCLUDE THE ATTACHED LETTER FROM MEDTRONIC PHYSIO-CONTROL CORP WITH THIS UPDATE. AT THIS TIME THE EXACT CAUSE FOR THESE INCIDENTS IS STILL BEING INVESTIGATED. WE PRESENTLY FEEL THAT MEDTRONIC PHYSIO-CONTROL CORP IS INTERESTED IN DETERMINING THE SOURCE OF THESE PROBLEMS AND ADDRESSING THE NEEDS FOR ITS CORRECTION. ALL FIRE SVC, LAW ENFORCEMENT PERSONNEL AND OTHER USERS OF AED EQUIPMENT SHOULD STILL BE COGNIZANT OF THE POTENTIAL SAFETY HAZARD, BUT TEMPER THAT WITH THE FACT THAT THESE DEVICES ARE STILL AN IMPORTANT PIECE OF LIFESAVING EQUIPMENT. AT THIS TIME ANY DISCONTINUANCE OF USE MUST BE AN AGENCY DECISION. IF YOU HAVE ANY QUESTIONS OR CONCERNS YOU MAY CONTACT SERVICE, MEDTRONIC PHYSIO-CONTROL CORP." MEDTRONIC LETTER TO CUSTOMER: "THIS LETTER IS TO PROVIDE YOU WITH ACCURATE AND UP-TO-DATE INFO ABOUT AN INCIDENT INVOLVING THE LITHIUM BATTERIES USED IN SOME LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORS. WE ARE CONCERNED THAT SOME PRESS AND E-MAIL MESSAGES BEING CIRCULATED ARE NOT ONLY INCORRECT BUT MAY CAUSE UNNECESSARY CONCERN. SINCE THE LIFEPAK 500 AED WAS INTRODUCED TWO AND ONE-HALF YEARS AGO THERE HAVE BEEN FOUR DOCUMENTED CASES OF SUDDEN VENTING OF A LITHIUM BATTERY, NONE INVOLVING PT APPLICATIONS. IN ONE CASE REPORTED TO US ON FRIDAY, OCTOBER 15, THE BATTERY WAS BEING HANDLED BY A FIREFIGHTER AND CAUSED A MINOR INJURY; HE AND A CO-WORKER WERE TREATED AND DISCHARGED FROM A LOCAL EMERGENCY ROOM. ALL BATTERIES, WHETHER USED IN A MEDICAL DEVICE, YOUR CELL PHONE, A FLASHLIGHT OR ANY OTHER APPLICATION, ARE CHEMICAL PACKAGES THAT GENERATE AND STORE ELECTRICAL ENERGY, AND HAVE THE POTENTIAL TO VENT OR RUPTURE. THE INCIDENCE OF THIS PROBLEM IS RARE. WE HAVE HAD FOUR OCCURRENCES IN A POPULATION OF APPROXIMATELY 144,000 LITHIUM CELLS USED IN PHYSIO PRODUCTS, SOME OF WHICH HAVE BEEN IN SVC MORE THAN TWO YEARS. WORLDWIDE, THERE ARE ANOTHER 360,000 CELLS IN USE IN OTHER APPLICATIONS; WE HAVE BEEN ADVISED OF ONE OTHER SIMILAR INCIDENT IN THIS ADD'L POPULATION. WE, IN CONJUNCTION WITH THE BATTERY MFR, ARE CONDUCTING AN EVALUATION OF THE FOUR CELLS WHICH HAVE VENTED TO ENSURE THE VENTING WAS NOT DUE TO AN AVOIDABLE CIRCUMSTANCE. FROM OUR INITIAL REVIEW THERE IS NO INDICATION TO DATE OF SUCH A CAUSE. WE ARE CONTINUING OUR EVALUATION AND INTEND TO EXHAUST ALL POSSIBILITES. OUR COMMITMENT IS TO PROVIDE LIFESAVING TOOLS TO PREVENT UNNECESSARY DEATH DUE TO SUDDEN CARDIAC ARREST. WE ARE ALSO COMMITTED TO PROTECT OUR CUSTOMER'S SAFETY WITHOUT REDUCING THE POSITIVE EFFECT FROM HAVING THESE LIFESAVING DEVICES IN PLACES WHERE SUDDEN CARDIAC ARREST MAY OCCUR. WE REMAIN CONVINCED THIS BATTERY TECHNOLOGY IS APPROPRIATE FOR USE IN AED'S. WE RECOMMEND THAT YOU KEEP YOUR DEVICES IN SVC. WE STAND BEHIND THE QUALITY OF OUR PRODUCTS. IF, AT ANY TIME, YOU HAVE QUESTIONS ABOUT THIS ISSUE OR CONCERNS ABOUT ANY MEDTRONIC PHYSIO-CONTROL PRODUCT, PLEASE CALL OUR CUSTOMER HOTLINE AT 1-800-732-3088."