BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2844991 · Received October 24, 2012

    Report

    Report Number
    3003793491-2012-00125
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ON THE PATIENT THE LIFE BAND RETRACTED AND STOPPED AND NOTHING ELSE HAPPENED. MANUAL CPR WAS THEN INITIATED. IT WAS ALSO REPORTED THAT PATIENT WAS OK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other