BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERIES

    MDR report key: 2981303 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00405
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "BATTERIES HAVE FAILED TESTING" WAS VERIFIED. THIS BATTERY, IDENTIFIED WITH SERIAL #(B)(4), WAS NOT MAINTAINED AS REQUIRED. BATTERY MAINTENANCE PROGRAM GUIDE INDICATES: "EACH BATTERY SHOULD BE TEST-CYCLED A MINIMUM OF ONCE A MONTH TO MAINTAIN OPTIMAL PERFORMANCE." THE BATTERY WAS MANUFACTURED IN JULY 2010. IT WAS TEST CYCLED 15 TIMES INSTEAD OF 26. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES HAVE FAILED TESTING MULTIPLE TIMES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36366 AUTOPULSE NIMH BATTERIES NIMH BATTERIES DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other