BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® NIMH BATTERY

    MDR report key: 4103278 · Received September 19, 2014

    Report

    Report Number
    3010617000-2014-00475
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NIMH BATTERY S/N (B)(4) ASSOCIATED WITH THIS COMPLAINT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE BATTERY WAS PLACED INTO THE BATTERY TESTER AND THE RESULTS INDICATED THAT THE BATTERY WAS BELOW THE MINIMUM POWER OUTPUT WATTS OF 1300W WITH A READING OF 724.5W. THE BATTERY WAS THEN FULLY CHARGED AND TEST CYCLED, THEN RE-TESTED WITH THE BATTERY TESTER, WHERE THE RESULTS INDICATED THAT THE BATTERY WAS STILL BELOW THE MINIMUM POWER OUTPUT WATTS OF 1300W WITH A READING OF 1080.7W. 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 11/2011 AND FOUND THE PROPER AMOUNT OF TEST CYCLES (34 +/- 1 EXPECTED, 18 PERFORMED) HAD NOT BEEN 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.

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A TRAINING SESSION, THE AUTOPULSE PLATFORM STOPPED COMPRESSIONS AFTER APPROXIMATELY 7 MINUTES, WHILE USING A FULLY CHARGED AUTOPULSE NIMH BATTERY WITH SERIAL NUMBER (SN) (B)(4). CUSTOMER RESTARTED THE PLATFORM; HOWEVER, THE REPORTED ISSUE DID NOT RESOLVE. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582613 AUTOPULSE® NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-0702-01

    Patients

    Seq Age Sex Outcome Treatment
    1