FDA Adverse Event Death Summary report: N

PHYSIO-CONTROL

MDR report key: 193085 · Received October 6, 1998

Report

Report Number
193085
Event Type
Death
Date Received
October 6, 1998
Date of Event
October 4, 1998
Report Date
October 5, 1998
Manufacturer
PHYSIO-CONTROL CORP.
Product Code
LDD
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
PARAMEDIC

Narratives

Description of Event or Problem · 1

DEFIBRILLATOR FAILED TO RECHARGE TO CAPACITY AFTER 200 JOULE DEFIBRILLATION. MEDIC UNIT, STAFFED BY EMERGENCY MEDICAL TECHNICIAN-PARAMEDIC AND EMERGENCY MEDICAL TECHNICIAN-1 RESPONDED TO A CALL FOR AN "UNCONSCIOUS SUBJECT, ALONG WITH FIRE DEPT. WHEN MEDIC UNIT ARRIVED ON SCENE (13:29) THEY FOUND PT TO ACTUALLY BE IN CARDIAC ARREST. THE CREW BEGAN TO TREAT PT PER PROTOCOL. THE PT WAS FOUND TO BE IN VENTRICULAR FIBRILLATION. THE PT WAS SHOCKED ONE TIME AT 200 JOULES, BUT PT COULD NOT BE DEFIBRILLATED FURTHER DUE TO FAILURE OF THE LIFEPACK 10 TO FULLY CHARGE TO CAPACITY. THE CREW TRIED ALL THREE BATTERIES IN THE LIFEPACK, AS WELL AS THE SPARE IN THE AIRWAY BOX. MEDIC UNIT REQUESTED A BACKUP UNIT AT 13:39. ANOTHER MEDIC UNIT ARRIVED AT 13:45, AND MONITORING WAS RESUMED, PT FOUND TO BE ASYSTOLE. NO FURTHER SHOCKS WERE INDICATED THROUGHOUT THE CALL. AFTER CLEARING FROM HOSP, MEDIC UNIT REPORTED TO EMERGENCY MEDICAL SVS BASE TO REPORT INCIDENT. STAFF STARTED TRYING BATTERIES IN THE LIFEPACK IN QUESTION. STAFF REPORTED THAT 12 BATTERIES THAT WERE IN THE "CHARGED" AREA IN DISPATCH HAD FAILED IN THE UNIT. STAFF HAD BEEN ABLE TO LOCATE 3 BATTERIES THAT WOULD FUNCTION. RPTR GOT A DIFFERENT LIFEPACK AND TRIED THE TWELVE BATTERIES, WITH SIMILAR RESULTS. RPTR PULLED THE LIFEPACK OUT OF SVC,MARKED IT OUT OF SVC, AND LEFT A NOTE DESCRIBING PROBLEM ON IT, WITH INSTRUCTIONS FOR STAFF TO HAVE IT SENT TO BIO-MED FOR TESTING. THEIR LIFEPACK WAS REPLACED WITH LIFEPACK 10 # 7, WHICH CAME OF DC-16 WHICH IS OUT OF SVC DUE TO ELECTRICAL PROBLEMS. RPTR INSTRUCTED STAFF TO FINISH THEIR REPORT AND TO WRITE A STATEMENT DESCRIBING WHAT HAD OCCURRED. RPTR HAS FILLED OUT AN INCIDENT REPORT. RPTR PLACED THE BATTERIES IN QUESTION, BACK IN THE "NEED CHARGING" AREA AND IMMEDIATELY BEGAN TO RECHARGE THEM, DUE TO A SERIOUS CONCERN OF RUNNING OUT OF CHARGED BATTERIES. WHILE WORKING A CARDIAC ARREST CODE, EQUIPMENT FAILUE WAS NOTED OF MONITOR #1. AFTER DEFIBRILLATING PT ONE TIME AT 200 JOULES FOR TREATMENT OF VENTRICULAR FIBRILLATION, PT REMAINED IN SAME RHYTHM. ATTEMPT TO DEFIBRILLATE FURTHER COULD NOT BE COMPLETED DUE TO PROBLEMS WITH EITHER MONITOR OR MONITOR BATTERIES. WHILE CHANGING FOR SHOCK, MONITOR BRIEFLY BLINKED OFF AND APPARENTLY DUMPED CHARGE. SECOND ATTEMPT OF SAME BATTERY WAS UNSUCCESSFUL WITH SAME OUTCOME. AFTER SWITCHING TO BATTERY #2, SAME RESULT WITH CHANGING. THIRD BATTERY PROVIDED NO SUCCESS FOR SAME REASON. AT NO TIME DID THE BATTERY LEVEL READ AS LOW OR LIGHT CAME ON TO INDICATE AS SUCH. SPARE BATTERY WAS PLACED WITH SAME RESULT. AFTER ATTEMPTING TO TRY BATTERY #2 AND 3, ALL BATTERY LOW LIGHTS CAME ON AND MONITOR SCREEN BLINKED SEVERAL TIMES BEFORE GOING BLANK. ADD'L MEDIC UNIT WAS REQUESTED FOR MONITOR AND BATTERIES. UPON THEIR ARRIVAL AND MONITORING WAS RSTORED WITH THEIR BATTERIES, PT WAS FOUND TO BE IN ASYSTOLE, WITHOUT CHANGE FOR REMAINDER OF PT CONTACT. BATTERIES AT BEGINNING OF SHIFT HAD BEEN TESTED, AND TWO HAD IN FACT BEEN CHANGED (AFTER BEING TESTED FOR CHARGE). AFTER CALL, STAFF WENT TO EMS BASE AND FOUND 12 BATTERIES AT EMS BASE THAT WERE SUPPOSEDLY CHARGED WOULD INDICATE EITHER NO CHARGE OR LOW BATTERY IN THEIR MONITOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHYSIO-CONTROL MONITOR/DEFIBRILLATOR LDD PHYSIO-CONTROL CORP. LIFE PAK 10 *

Patients

Seq Age Sex Outcome Treatment
1 66 YR Death