BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3063018 · Received March 26, 2013

    Report

    Report Number
    3003793491-2013-00414
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "SYSTEM ERROR, OUT OF SERVICE. REVERT TO MANUAL CPR" WAS CONFIRMED. THE PROCESSOR BOARD WAS FOUND TO BE AT FAULT; IT WAS REPLACED. ADDITIONALLY, THE REVIEW OF ARCHIVE FILE SHOWED NUMEROUS USER ADVISORY 136 (INTERNAL PARAMETER CORRUPTED). NO OTHER ISSUE WAS FOUND IN THE ARCHIVE FILE. PLATFORM PASSED THE FINAL TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRAINING DEMO, THE PLATFORM POWERED ON AND DISPLAYED "SYSTEM ERROR, OUT OF SERVICE. REVERT TO MANUAL CPR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123045 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other