BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2954290 · Received January 9, 2013

    Report

    Report Number
    3003793491-2013-00041
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF BROKEN RESTRAINT AND INTERMITTENT OPERATION WAS CONFIRMED. TOP COVER WAS DAMAGED AND ONE OF THE LOAD CELLS WAS WORKING INTERMITTENTLY. DEFECTIVE/DAMAGED PARTS WERE REPLACED, PLATFORM PASSED FINAL TEST. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLATFORM¿S HEAD RESTRAINT WAS BROKEN AND THAT THERE WERE INTERMITTENT PROBLEMS DURING CARDIAC ARREST. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11341 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other