BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3161692 · Received May 23, 2013

    Report

    Report Number
    3003793491-2013-00601
    Event Type
    Death
    Date Received
    May 23, 2013
    Date of Event
    April 29, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE 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. PLEASE SEE RELATED MFR REPORT #3003793491-2013-00599 FOR COMPLAINT AGAINST THE PLATFORM (SN (B)(4)) AND 3003793491-2013-00600 FOR COMPLAINT AGAINST BATTERY WITH (SN (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM FAILED ON A FULL-ARREST PT. THE PLATFORM GAVE 15 COMPRESSIONS ON ONE BATTERY (SN (B)(4)) AND 2 COMPRESSIONS ON A SECOND BATTERY (SN (B)(4)). THE UNIT HAS BEEN TAKEN OUT OF SERVICE UNTIL FURTHER NOTICE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: MANUAL CPR WAS INITIATED. PT WAS PRONOUNCED DEAD. THE CAUSE OF DEATH WAS NOT PROVIDED. THIS REPORT WILL COVER THE COMPLAINT AGAINST THE AUTOPULSE NIMH BATTERY (SN (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228208 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC. 8700-0702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MANUAL CPR