BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2901875 · Received November 20, 2012

    Report

    Report Number
    3003793491-2012-00287
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE DISPLAYED "SYSTEM ERROR" WHEN POWERED ON.

    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