BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® NIMH BATTERY

    MDR report key: 3920371 · Received July 8, 2014

    Report

    Report Number
    3003793491-2014-00328
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE THE FOLLOWING RELATED MFR REPORT: 3003793491-2014-00326 TO ADDRESS THE SECOND INCIDENT. PRODUCT IN COMPLAINT WILL NOT BE RETURNED. THEREFORE, PHYSICAL INVESTIGATION CANNOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IN COMPLAINT IS RETURNED AND INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHEN THE USER TOOK THE AUTOPULSE NIMH BATTERY FROM THE CHARGER, THE BATTERY TOUCHED THE SNAP FASTENER OF THE PHYSICIAN'S SMOCK WHICH RESULTED IN A BURN IN BOTH THE SMOCK AND THE BATTERY CONNECTOR. THE PHYSICIAN FELT A SMALL SHOCK BUT DID NOT LOSE CONSCIOUSNESS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397777 AUTOPULSE® NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-0702

    Patients

    Seq Age Sex Outcome Treatment
    1