BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE 100

    MDR report key: 2935633 · Received January 24, 2013

    Report

    Report Number
    MW5028788
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 24, 2013
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT CODED. AUTOPULSE RESUSCITATION DEVICE WAS PUT IN PLACE. DEVICE WAS POWERED ON AND OPERATED FOR APPROX 5 MINUTES AND THE BATTERY FAILED. A SECOND AND THIRD BATTERY WERE INSTALLED, BOTH LASTING APPROX. 2 MINUTES. MANUAL CPR WAS INITIATED BETWEEN BATTERY CHANGES AND FOLLOWING LAST BATTERY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34679 AUTOPULSE 100 RESUSITATION SYSTEM DRM ZOLL CIRCULATION AUTOPULSE 100

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR