BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® NIMH BATTERY

    MDR report key: 3816783 · Received May 19, 2014

    Report

    Report Number
    3003793491-2014-00245
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE BATTERY IN COMPLAINT WAS RETURNED TO ZOLL ON 06/09/2014 FOR INVESTIGATION. THE BATTERY WAS PLACED IN THE BATTERY TESTER, AND THE RESULTS INDICATED THAT THE BATTERY WAS BELOW THE MINIMUM POWER OUTPUT WATTS OF 1300W WITH A READING OF 1028.6W. THE BATTERY WAS THEN FULLY CHARGED AND TEST CYCLED, THEN RE-TESTED WITH THE BATTERY TESTER, WHERE THE RESULTS INDICATED THAT THE BATTERY WAS ABOVE THE MINIMUM POWER OUTPUT WATTS OF 1300W WITH A READING OF 1341.1W. AN INVESTIGATION CONDUCTED USING THE BATTERY'S SERIAL NUMBER FOUND THAT THE BATTERY WAS WITHIN ITS EXPECTED LIFE SPAN OF 2-4 YEARS WITH A MANUFACTURE DATE OF 4/2013, AND THE PROPER AMOUNT OF TEST CYCLES (10 +/- 1 EXPECTED, 10 PERFORMED) WERE PERFORMED. THE EXPECTED SERVICE LIFE OF THE AUTOPULSE BATTERY IS 100 CHARGE CYCLES OR 2 TO 4 YEARS DEPENDING ON BATTERY MAINTENANCE AND USAGE PATTERNS. BOTH OF THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE CONFIRMED AS THE BATTERY PASSED TESTING AND WAS ABLE TO POWER ON A PLATFORM AT ZOLL.

    Additional Manufacturer Narrative · 1

    ZOLL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE NIMH BATTERY WOULD NOT POWER ON AN AUTOPULSE PLATFORM. CUSTOMER ALSO STATED THAT THE BATTERY WILL NOT CHARGE IN A MULTI-CHEMISTRY CHARGER. HOWEVER, ONE GREEN LED LIGHT IS DISPLAYED AT THE END OF THE BATTERY (INDICATING THAT THE BATTERY IS FULLY CHARGED AND READY FOR USE). NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297651 AUTOPULSE® NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-0702-01

    Patients

    Seq Age Sex Outcome Treatment
    1