BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3161638 · Received May 23, 2013

    Report

    Report Number
    3003793491-2013-00603
    Event Type
    Death
    Date Received
    May 23, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WILL NOT BE RETURNED TO ZOLL CIRCULATION. THEREFORE, PHYSICAL INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT CARE, THE LIFEBAND WAS FOUND TO WRINKLE DURING COMPRESSIONS. PT APPEARED LARGER AND WIDER ON THE PLATFORM, ROUGHLY (B)(6) POUNDS. BECAUSE OF THIS, MEDICS DISCONTINUED USE OF THE AUTOPULSE PLATFORM. MANUAL CPR WAS PERFORMED FOR THE REMAINDER OF THE CALL. PT DID EXPIRE. THE CAUSE OF DEATH WAS NOT PROVIDED. MFR REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER ON (B)(4) 2013 AND (B)(4) 2013. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228211 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death MANUAL CPR