BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2935797 · Received January 2, 2013

    Report

    Report Number
    3003793491-2012-00704
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FAN DOESN'T COME ON AND DOESN'T MAKE CLICKING SOUND AS USUAL. WHEN PRESSING THE GREEN BUTTON, IT SAYS THAT IT IS ANALYZING THE PT BUT NOTHING HAPPENS. THE BAND DOESN'T SIZE THE PT OR MOVE AT ALL. TRIED SPINNING THE PIN IN THE BACK, READJUSTING THE BAND, PULLING UP THE BAND, STILL DOES NOT WORK. ALSO, THE DEVICE HAS A SMALL CRACK IN THE TOP RIGHT CORNER BUT DON'T THINK IT HAS ANYTHING TO DO WITH THE OPERATION OF THE BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other