BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 745838 · Received August 8, 2006

    Report

    Report Number
    9610483-2006-00164
    Event Type
    Other
    Date Received
    August 8, 2006
    Date of Event
    January 26, 1999
    Report Date
    February 2, 1999
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    MKJ
    PMA / PMN Number
    K896919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED USING A KNOWN GOOD POWER SOURCE AND PROPER OPERATION WAS VERIFIED. USING THE 2 EXPIRED NON-LAERDAL BATTERIES (LOTS 910828 & 930916), THE DEFIBRILLATOR DELIVERED 1 SHOCK WITH BATTERY LOT 930916 BEFORE SHUTTING THE DIFIBRILLATOR DOWN WITH A PROMPT OF "REPLACE BATTERY, BATTERY LOW" AND WAS UNABLE TO SHOCK AT ALL USING BATTERY LOT 910828, SHUTTING THE UNIT DOWN DURING THE CHARGE CYCLE PROMPTING "REPLACE BATTERY, BATTERY LOW". BOTH BATTERIES FAILED THE BATTERY CAPACITY TEST DEFINED IN THE HS3000 OPERATING INSTRUCTIONS. THE RETURNED MCM INCIDENT REPORT DOCUMENTS THE UNIT FIRST SHUT DOWN WITH A PROMPT OF "REPLACE BATTERY, BATTERY LOW", THEN CHARGED AND DELIVERED A 200J SHOCK, AND AFTER THE 3RD POWER-ON, ABORTED CHARGE PROMPTING "NO SHOCK INDICATED". A "REPLACE BATTERY, BATTERY LOW" MESSAGE PROMPTS WHEN THE BATTERY LACKS THE CAPACITY TO PERFORM AS REQUIRED AND THE DEFIBRILLATOR SHUTS DOWN. THE HS3000 OPERATING INSTRUCTIONS EXPLAIN BATTERY LIFE AND MAINTENANCE, RECOMMENDING USE OF ONLY LAERDAL APPROVED BATTERIES, PERIODIC BATTERY CAPACITY TESTS AND REPLACEMENT AFTER 2 YRS. GREGG BURZINE WAS SENT A LETTER, WITH A COPY TO MARK STEFFENS, EXPLAINING OUR EVAL AND THAT NON-LAERDAL BATTERIES ARE NOT RECOMMENDED FOR USE WITH THE HS3000 DEFIBRILLATOR.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 1999 INVOLVING A FEMALE PT IN WITNESSED CARDIAC ARREST, THIS DEFIBRILLATOR ANALYZED AND CHARGED, BUT DUMPED THE CHARGE INDICATING A LOW BATTERY CONDITION. THE BATTERY WAS CHANGED, THE RHYTHM ANALYZED, AND THE DEFIBRILLATOR CHARGED AND SHOCKED ONCE AT 200J. ALS ARRIVED AND TOOK OVER PT CARE USING THEIR EQUIPMENT. THE PT WAS PRONOUNCED AT THE SCENE AFTER TELEMETRY CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL A/S HS3000 9608

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other