BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2981297 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00304
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    July 6, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY IDENTIFIED WITH S/N (B)(4) HAD BEEN PROPERLY MAINTAINED; A PROBABLE CAUSE FOR ITS LOW POWER OUTPUT CANNOT BE DETERMINED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 AUTOPULSE BATTERIES FAILED. BATTERIES WERE MANUFACTURED ON 02/2011 AND 03/2011. BOTH BATTERIES HAD BEEN CYCLED AND CAPACITY TESTED THE PREVIOUS MONTH AND FOUND TO HAVE LOWER THAN EXPECTED OUTPUTS. BOTH BATTERIES FAILED ON THE CHARGER AND HAD FLASHING RED LIGHTS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36506 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other