BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2983196 · Received January 31, 2013

    Report

    Report Number
    3003793491-2013-00246
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    October 11, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "DEVICE STOPPED COMPRESSIONS AND SHOWED USER ADVISORY 45" WAS NOT VERIFIED. FURTHERMORE, THERE WAS NO INDICATION OF UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESET) IN THE ARCHIVE FILE. PLATFORM PASSED FUNCTIONAL AND FINAL TESTS. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC ARREST, THE DEVICE STOPPED COMPRESSIONS AND USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESET) WAS SHOWN. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43726 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other