BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3112001 · Received April 30, 2013

    Report

    Report Number
    3003793491-2013-00496
    Event Type
    Death
    Date Received
    April 30, 2013
    Date of Event
    January 30, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. (REFER TO 30003793491-2013-00497 FOR OTHER PT).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE PLATFORM WAS PLACED ON PTS, THE AUTOPULSE WILL SIZE, BUT WILL NOT START COMPRESSIONS. THE PLATFORM WOULD EITHER TURN OFF OR DISPLAY A RE-ALIGN PT ERROR MESSAGE. NO ADVERSE PT SEQUELAE WAS REPORTED AT THE TIME. DESPITE SEVERAL ATTEMPTS, NO OTHER INFORMATION COULD BT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186338 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other