BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2935814 · Received January 2, 2013

    Report

    Report Number
    3003793491-2012-00715
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE NIMH BATTERY (SN (B)(4)) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL MEDICAL CORPORATION ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE BATTERY SHOWED NO DAMAGES. REPORTED COMPLAINT WAS CONFIRMED DURING TESTING. THE PROBLEM APPEARS TO BE THE CUSTOMER'S BATTERY SN (B)(4) WHICH IT RAN FOR A FEW COMPRESSIONS AND STOPPED AND THEN DISPLAYED "LOW BATTERY" AND "REPLACE BATTERY" MESSAGES. THE ARCHIVE FILE SHOWS LOW VOLTAGE BATTERY WAS USED DURING COMPRESSIONS. FURTHERMORE, THE BATTERY FAILED TESTING AND WILL BE SCRAPPED. PROBABLE CAUSE FOR BATTERY FAILING COULD BE DUE TO AGING (MANUFACTURED IN MARCH 2009) OR IMPROPER BATTERY MAINTENANCE. THE CALENDAR AGE OF THE BATTERY IS GREATER THAN 2 YEARS. THE PRODUCT LABELING INSTRUCTS THAT THE USEFUL LIFE OF EACH AUTOPULSE BATTERY IS BETWEEN 2 - 4 YEARS. AS WITH ALL BATTERIES, THE NIMH BATTERY CHEMISTRY HAS A FINITE CALENDAR LIFE. WITHIN THE 2 - 4 YEAR LIFE RANGE, THE LIFE OF EACH BATTERY IS INFLUENCED BY THE FREQUENCY OF USE AND THE FREQUENCY OF ROUTINE BATTERY MAINTENANCE. BATTERY SERIAL NUMBER (B)(4) WAS RECEIVED AND SERVICED ON (B)(6) 2012. THE AUTOPULSE SYSTEM LABELING REQUIRES THE USER TO "TEST CYCLE" EACH BATTERY MONTHLY. THE NUMBER OF TEST CYCLES OBTAINED FOR THIS BATTERY WAS "32" CYCLES. IF PROPER BATTERY MANAGEMENT HAD BEEN FOLLOWED, THE EXPECTED NUMBER OF TEST CYCLES WOULD BE "43." NO FOLLOWING RECOMMENDED BATTERY MAINTENANCE MAY RESULT IN FASTER AGING. THIS LACK OF TEST CYCLES MAY HAVE CONTRIBUTED TO THE BATTERY END OF LIFE. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOARD WILL LAST ONLY 2 MINUTES BEFORE SHUTTING DOWN. PER BIOMED, THE BATTERY IS TESTED EVERY 30 DAYS AND IS FULLY CHARGED BEFORE PLACING INTO THE BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other