BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2982193 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00295
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "DESPITE FOLLOWING PROPER BATTERY MGMT, BATTERIES WERE FOUND TO GIVE LOW RUN TIMES OF 10 MINUTES EACH OR LESS" COULD NOT BE VERIFIED BECAUSE THE BATTERIES WERE NOT RETURNED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE FILED IF THE BATTERIES ARE RETURNED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DESPITE FOLLOWING PROPER BATTERY MGMT, BATTERIES WERE FOUND TO GIVE LOW RUN TIMES OF 10 MINUTES EACH OR LESS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35494 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other