BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3130992 · Received May 13, 2013

    Report

    Report Number
    3003793491-2013-00547
    Event Type
    Death
    Date Received
    May 13, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS REC'D THE DEVICE ASSOCIATED WITH THIS REPORT; HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM FAILED TWICE WHILE USING IT ON A PT. THEY REVERTED TO MANUAL CPR BUT THE PT DID NOT SURVIVE. THE EXACT CAUSE OF DEATH WAS NOT PROVIDED. THE CUSTOMER STATED THAT THEY TRIED TWO DIFFERENT BATTERIES BUT THEY BOTH FAILED IN TWENTY SECONDS OR LESS. HOWEVER, AFTER THE CALL THE CUSTOMER WAS ABLE TO RUN THE PLATFORM WITH THE BATTERIES IN QUESTION FOR ALMOST AN HOUR WITH A TEST MANIKIN. THE CUSTOMER ALSO STATED THAT BY THE TIME THEY GOT THEIR IN-SVC AND STARTED USING THE BOARD IN THE FIELD IT WAS ALMOST APRIL LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211712 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MANUAL COMPRESSION