BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 775317 · Received August 30, 2006

    Report

    Report Number
    9610483-2006-00196
    Event Type
    Other
    Date Received
    August 30, 2006
    Date of Event
    August 11, 1999
    Report Date
    August 11, 1999
    Manufacturer
    LAERDAL MEDICAL, A.S.
    Product Code
    MKJ
    PMA / PMN Number
    K896919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED USING A KNOWN GOOD POWER SOURCE AND PROPER OPERATION FOR PATIENT TREATMENT WAS VERIFIED. THE RETURNED BATTERY, LAERDALE LOT 980319, AS RETURNED DELIVERED SEVERAL SHOCKS BEFORE PROMPTING "LOW BATTERY". THIS BATTERY WOULD FAIL THE PERIODIC BATTERY CAPACITY TEST AS DEFINED IN THE HS3000 OPERATING INSTRUCTIONS. THE BATTERY WAS CHARGED AND RETESTED TO FIND THAT IT DELIVERED 8 SHOCKS BEFORE THE "REPLACE BATTERY, BATTERY LOW" WARNING AND SHUT OFF. THE BATTERY WAS RECHARGED AGAIN AND IT THEN DELIVERED 9 SHOCKS BEFORE THE "LOW BATTERY" PROMPT AND 15 MORE SHOCKS BEFORE THE "REPLACE BATTERY, BATTERY LOW" PROMPT. LAERDAL RECOMMENDS BATTERIES BE CONTINOUSLY CHARGED WHEN NOT IN USE. IMPROPER BATTERY MAINTENANCE COULD BE CONTRIBUTING FACTOR WITH THIS BATTERY. THE HS3000 OPERATING INSTRUCTIONS EXPLAIN BATTERY LIFE AND MAINTENANCE. THE CUSTOMER WAS SENT A LETTER EXPLAINING OUR EVALUATION AND RECOMMENDING BATTERIES BE KEPT ON CHARGE WHEN NOT IN USE.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 1999, INVOLVING A MALE PT IN V-FIB, THIS DEFIBRILLATOR ANALYZED, CHARGED AND COMMITED TO TREAT, BUT THEN SHUT OFF. THIS HAPPENED 3 TIMES. THEY CONTINUED WITH CPR FOR 5 MINUTES UNTIL AN ALS CREW ARRIVED AND TOOK OVER PATIENT CARE. THE PATIENT WAS TRANSPORTED TO A HOSPITAL AND WAS BELIEVED TO BE STILL ALIVE. THE CREW DID NOT HAVE A SECOND BATTERY WITH THEM AND THE BATTERY THEY WERE USING WAS PURCHASED IN FEB 99. CAPTAIN FLOOD BELIEVED THE BATTERY MAY HAVE BEEN USED FOR MONITORING PRIOR TO THIS EVENT, SO IT IS POSSIBLE THAT THE BATTERY WAS LOW, BUT A LOW BATTERY MESSAGE DID NOT OCCUR DURING THAT MORNING'S TEST. HE WAS CONCERNED BECAUSE, EVEN IF THEY DID GET A LOW BATTERY MESSAGE ON A CALL, THEY SHOULD HAVE HAD ANOTHER COUPLE OF SHOCKS LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL, A.S. HS3000QR 9410

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other