BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3017842 · Received March 18, 2013

    Report

    Report Number
    3003793491-2013-00340
    Event Type
    Death
    Date Received
    March 18, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PT EVENT, PLATFORM STOPPED WITHOUT INDICATING A USER ADVISORY. DEVICE WAS TESTED, AFTER 2 COMPRESSIONS DEVICE STOPPED. RESUSCITATION WAS TERMINATED AFTER A FEW MINUTES. MANUAL CPR WAS ADMINISTERED BEFORE AND AFTER USE OF THE PLATFORM. THERE WAS NO DELAY IN TREATMENT. BUT PT DID NOT SURVIVE. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111914 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death