BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® NIMH BATTERY

    MDR report key: 3920356 · Received July 8, 2014

    Report

    Report Number
    3003793491-2014-00326
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 10, 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: 3003793491-2014-00328 TO ADDRESS THE FIRST INCIDENT. ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    NIMH BATTERY (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED BATTERY FOUND ONE OF THE GUIDING PINS AND BATTERY PINS TO BE DAMAGED. BECAUSE OF THE NOTED DAMAGE, THE BATTERY WAS UNABLE TO BE TESTED DUE TO THE POSSIBILITY OF SHOCK/BURN/SHORT. THE ELECTRICAL CONNECTOR'S EXTENSION BEYOND THE BATTERY'S FACE WAS CHECKED RELATIVE TO THE PROTECTIVE ALIGNMENT PINS AND VISUAL INSPECTION OF THE RETURNED BATTERY FOUND ONE OF THE GUIDING PINS AND ONE OF THE BATTERY PINS TO BE DAMAGED. IT IS NOT KNOWN WHETHER THE NOTED DAMAGE OCCURRED BEFORE OR AFTER THE REPORTED INCIDENT. ACCIDENTAL CONTACT BETWEEN TERMINALS AND METAL OBJECT IS CONSIDERED A USE ERROR. ZOLL SHIPS BATTERIES WITH A PROTECTIVE NON-CONDUCTING CAP ON TERMINALS. ALSO, THE BATTERY USER GUIDE (P/N 10762-001, SECTION 5.2) INCLUDES A CAUTION STATEMENT: "DO NOT SHORT THE BATTERY POWER LEADS. ELECTRICAL CONNECTION (SHORT) BETWEEN BATTERY POWER LEADS ON THE CONNECTOR PERMANENTLY DAMAGES THE BATTERY AND RENDERS THE BATTERY INOPERABLE". AN INVESTIGATION CONDUCTED USING THE BATTERIES SERIAL NUMBER, FOUND THAT THE BATTERY WAS WITHIN ITS EXPECTED LIFE SPAN OF 2-4 YEARS, WITH A MANUFACTURE DATE OF 8/2012. THE EXPECTED SERVICE LIFE OF THE AUTOPULSE BATTERY IS 100 CHARGE CYCLES OR 2 TO 4 YEARS DEPENDING ON BATTERY MAINTENANCE AND USAGE PATTERNS. AS THE TEST CYCLES WERE NOT LOGGED ON THE BATTERY, READINGS WERE UNABLE TO BE OBTAINED AND IT WAS UNABLE TO BE DETERMINED IF THE BATTERY WAS PROPERLY MAINTAINED. IF PROPER BATTERY MAINTENANCE IS NOT PERFORMED (CHARGED/TEST CYCLED) AS INSTRUCTED PER THE IFU, THE BATTERIES LIFE SPAN WILL BE ADVERSELY EFFECTED.

    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. THIS IS THE SECOND TIME THIS INCIDENT OCCURRED AND IS ADDRESSED UNDER THIS MFR REPORT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397818 AUTOPULSE® NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-702

    Patients

    Seq Age Sex Outcome Treatment
    1