BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3140062 · Received May 20, 2013

    Report

    Report Number
    3003793491-2013-00583
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE BATTERY ((B)(4)) WAS RETURNED TO ZOLL CIRCULATION FOR EVALUATION AND WAS ANALYZED ON (B)(4) 2013. VISUAL INSPECTION REVEALED NO ANOMALIES. AFTER THE BATTERY WAS FULLY CHARGED/TEST CYCLED AND RETESTED, THE BATTERY WAS SUCCESSFULLY PASSED. RUN-IN TEST WITH THE 95% PATIENT TEST FIXTURE WAS PERFORMED UNTIL DISCHARGED FOR MORE THAN 40 MINUTES AND NO ISSUES WERE OBSERVED. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTOPULSE NIMH BATTERY EXPERIENCED LOW RUN TIMES. FIRST BATTERY (S/N (B)(4)) IS ADDRESSED UNDER (B)(4), MFR # 3003793491-2013-00582. ADDITIONAL INFORMATION WAS RECEIVED WHEREBY CUSTOMER INDICATED THAT THE UNIT JUST SHUT OFF. THE BATTERY RAN FOR APPROXIMATELY 2 MINUTES. THIS INCIDENT OCCURRED WHILE ATTEMPTING TO RESUSCITATE THE PATIENT. MANUAL CPR WAS INITIATED UNTIL ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS ACHIEVED. THE PATIENT DIED LATER THAT DAY. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223468 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC. 8700-0702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other