BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2924125 · Received December 14, 2012

    Report

    Report Number
    3003793491-2012-00399
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 17, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY SN (B)(4) WAS NOT RETURNED, BUT THE TEST DATA WAS PROVIDED. THIS BATTERY WAS TEST CYCLED AS REQUIRED AND BASED ON THE DATA PROVIDED, IT MET PERFORMANCE CRITERIA. HOWEVER, IT IS POSSIBLE THAT DAILY BATTERY SWAPS WERE NOT PERFORMED, AND/OR BATTERY WAS NOT FULLY CHARGED BEFORE DEPLOYMENT. THIS CAN CAUSE THE BATTERY TO NOT OPERATE CORRECTLY. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    FOR (B)(4), IT WAS REPORTED THAT 49 BATTERIES WERE NOT OPERATING CORRECTLY. FOR BATTERY SN (B)(4) REPORTED DESCRIPTION WAS THAT THE BATTERY RAN THE SYSTEM FOR ONLY 5 MINUTES. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1