BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL AUTOPULSE

    MDR report key: 1162765 · Received September 16, 2008

    Report

    Report Number
    MW5008317
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ZOLL
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMBULANCE CREW RESPONDED TO A 911 CALL AND FOUND PT IN FULL ARREST (ASYSTOLE) WITH CPR IN PROGRESS. THE PT WAS ATTACHED TO THE ZOLL AUTOPULSE (AUTOMATED CHEST COMPRESSION) DEVICE. AFTER APPROX TWO MINS OF OPERATION, THE DEVICE SHUTDOWN AND "BATTERY CHANGE" MESSAGE WAS NOTED. BATTERY WAS REMOVED AND FOUND TO BE FULLY CHARGED AND THEREFORE RE-INSERTED FOR USE. AGAIN, AFTER APPROX 2 MINS, THE DEVICE SHUTDOWN AND "BATTERY CHANGE" MESSAGE WAS NOTED. AFTER A TOTAL OF FIVE ATTEMPTS AND THREE BATTERY CHANGES, THE DEVICE WAS REMOVED AND MANUAL CPR WAS RESUMED. NOTE: MANUAL CPR WAS IN PROGRESS DURING THE TIME(S) THAT THE DEVICE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL AUTOPULSE NON-INVASIVE CARDIAC SUPPORT PUMP DRM ZOLL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other