BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 3942238 · Received July 17, 2014

    Report

    Report Number
    3003793491-2014-00341
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON 07/15/2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE® LI-ION BATTERY WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION RESULTS AS FOLLOWS: THE REPORTED COMPLAINT WAS CONFIRMED. ARCHIVE DATA ANALYSIS RESULTS INDICATED "GAS GAUGE COMMUNICATION FAULT". RANDOM ERRORS DUE TO NOISE OR ESD MAY TRIGGER A FAULT IN THE COMMUNICATION BETWEEN THE GAS GAUGE AND THE BATTERY PROCESSOR. IN MOST CASES, THE PROCESSOR IS ABLE TO CORRECT THE FAULT AND THE BATTERY CONTINUES TO FUNCTION NORMALLY. ON RARE OCCASIONS, THE FAULT CANNOT BE CORRECTED AND THE BATTERY CANNOT BE CHARGED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT ONE OF THEIR AUTOPULSE® LI-ION BATTERIES HAS A FAULT. THIS BATTERY HAS ONLY BEEN FUNCTIONING FOR HALF OF ITS EXPECTED LIFE. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED. PLEASE NOTE THAT THE DATE OF EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419641 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION, INC 8700-0752

    Patients

    Seq Age Sex Outcome Treatment
    1