BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2971894 · Received January 16, 2013

    Report

    Report Number
    3003793491-2013-00106
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    January 19, 2012
    Report Date
    February 1, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "THE PLATFORM RAN FOR ABOUT 3-4 MINUTES BEFORE THE DISPLAY FLICKERED AND THEN WENT BLANK" WAS NOT CONFIRMED. FURTHERMORE, AS INDICATED BY THE CUSTOMER, "A SECOND BATTERY WAS USED FOR THE REMAINDER OF THE CODE WITH NO PROBLEMS". THEREFORE, THE LIKELY CAUSE FOR THE PLATFORM FLICKERING AND GOING BLANK IS THE USE OF A WEAK BATTERY. UNRELATED TO THE ABOVE ISSUE, A LOAD CELL, WHICH IS THE DEVICE THAT ENSURES THE PATIENT IS PROPERLY PLACED ON THE PLATFORM, WAS FOUND TO BE DEFECTIVE. THE LOAD CELL, LOAD PLATE COVER AND SEALS WERE REPLACED. THE PLATFORM PASSED FINAL TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT CARE, THE PLATFORM RAN FOR 3-4 MINUTES BEFORE THE DISPLAY FLICKERED AND THEN WENT BLANK WITHOUT WARNING. CUSTOMER REPLACED THE BATTERY, WHICH WAS SHOWING A GREEN LIGHT WITH ANOTHER BATTERY. THE SECOND BATTERY RAN FOR THE REMAINDER OF THE CODE WITHOUT ANY PROBLEMS. AFTER ABOUT 4-5 MINUTES THE PATIENT WAS PRONOUNCED DEAD. IT WAS ALSO REPORTED THAT PATIENT HAD BEEN DOWN FOR A LITTLE WHILE AND WAS RECEIVING MANUAL CPR PRIOR TO MEDICS' ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25502 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1