BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3170712 · Received May 28, 2013

    Report

    Report Number
    3003793491-2013-00625
    Event Type
    Death
    Date Received
    May 28, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WITH SERIAL NUMBER 31763 WILL NOT BE RETURNED TO ZOLL CIRCULATION BY THE CUSTOMER FOR PHYSICAL INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM RAN FOR 15 MINUTES THEN "SHUT DOWN." THE PLATFORM WAS POWERED BACK ON AND IT WOULD RUN FOR ANOTHER 10 TO 15 MINUTES BEFORE "SHUTTING DOWN" AGAIN. THE CUSTOMER POWERED ON AGAIN AND THE PLATFORM REMAINED PUMPING FOR 10 TO 15 MINUTES. THE PLATFORM RAN FINE FOR THE LAST 20 MINUTES. THE AUTOPULSE WAS USED FOR ABOUT ONE HOUR. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED BUT NOT DUE TO THE FAULT OF THE DEVICE. THE EXACT CAUSE AND DATE OF DEATH WAS NOT PROVIDED. THE CUSTOMER REPORTED THAT MOST OF THE TIME, THE PLATFORM "SHUT OFF" WHEN IT WAS "SUSPENDED." IN ADDITION, THE CUSTOMER REPORTED THAT THEY WILL USE THE AUTOPULSE ON A MANIKIN WITH OTHER BATTERIES TO DETERMINE IF THE ISSUE ENCOUNTERED WAS DUE TO A BATTERY PROBLEM. THE BATTERIES USED ARE SERIAL NUMBERS (B)(4). THE CUSTOMER WAS NOT SURE WHICH BATTERY WAS USED DURING THE EVENT. A SPARE BATTERY WAS NOT USED AS IT WAS NOT IN THEIR REACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233522 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death