BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2945287 · Received December 31, 2012

    Report

    Report Number
    3003793491-2012-00555
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE NIMH BATTERY (S/N (B)(4)) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. THE ARCHIVE DATA ANALYSIS SHOWED CUSTOMER NOT FOLLOWING PROPER BATTERY MANAGEMENT PROCEDURES OF DAILY SYSTEM CHECKS AND BATTERY SWAP. IT ALSO SHOWED THAT THIS BATTERY WAS USED REPEATEDLY ON THE INCIDENT DATE WHICH WAS NOT FRESH OUT FROM THE CHARGER THEREFORE IT HAD LOW VOLTAGE. AFTER A FULLY CHARGED AND TEST CYCLE, THIS BATTERY FAILED THE POWER OUTPUT TESTING. PROBABLE CAUSE FOR BATTERY FAILING COULD BE DUE TO AGING (MANUFACTURED IN AUGUST 2009). 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. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE STOPPED DURING CLINICAL USE WHEN USING BATTERY S/N (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other