BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2868000 · Received November 29, 2012

    Report

    Report Number
    3003793491-2012-00416
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    July 19, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAY "USER ADVISOR 2" (COMPRESSION TRACKING ERROR) ON A PT. THE AUTOPULSE FAILED ON A PT, SO MANUAL CPR WAS APPLIED. PT DID NOT MAKE IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death