BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2935271 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00368
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY WAS NOT RETURNED FOR INVESTIGATION. THE CUSTOMER SCRAPPED THE FAILED BATTERY, BUT HAD TESTED IT AND PROVIDED THE DATA. BASED ON THIS DATA: BATTERY FAILED POWER TESTING. PRODUCT LABELING INDICATES THAT THE USEFUL LIFE OF THE BATTERY IS BETWEEN 2-4 YEARS. LIFE OF EACH BATTERY IS INFLUENCED BY FREQUENCY OF USE AND FREQUENCY OF ROUTINE MAINTENANCE. BATTERY MAINTENANCE RECORDS INDICATED THAT THIS BATTERY WAS NOT TEST CYCLED ON A MONTHLY BASIS). THIS BATTERY HAS AN ESTIMATED MANUFACTURING DATE OF MARCH-APRIL 2009. THE COMPLAINT WAS REPORTED IN (B)(6) 2012. THIS BATTERY WAS 3+ YEARS OLD AT THE TIME OF THE REPORTED EVENT. BASED ON THE CALENDAR AGE OF THIS BATTERY, IT MAY HAVE AGED PAST THE END OF ITS USEFUL LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS IN CARDIAC ARREST, DURING USE, DEVICE COMPRESSED ONCE AND DISPLAYED "REPLACE BATTERY". BATTERY WAS REPLACED, SYSTEM AGAIN COMPRESSED ONCE AND DISPLAYED REPLACE BATTERY. MANUAL CPR WAS ADMINISTERED. FOURTEEN AUTOPULSE NIMH BATTERIES WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36102 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death