BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE? RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3191774 · Received June 26, 2013

    Report

    Report Number
    3003793491-2013-00715
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE RESUSCITATION SYSTEM LED SCREEN DOES NOT LIGHT UP WHEN UNIT IS TURNED ON. ADDITIONALLY, THE SHAFT ON UNIT IS OUT OF THE HOME POSITION AND CANNOT BE MOVED. ALSO LIFEBAND CANNOT BE REMOVED. THIS INCIDENT WAS OBSERVED DURING A SHIFT CHECK THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290977 AUTOPULSE? RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1