BEUDAMED
    FDA Adverse Event Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2944314 · Received January 29, 2013

    Report

    Report Number
    3003793491-2012-00392
    Date Received
    January 29, 2013
    Date of Event
    May 30, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY WAS NOT RETURNED FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF IT IS RETURNED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERY SN (B)(4) MANUFACTURED IN 02/2011 WOULD NOT CHARGE. BATTERIES WITH SERIAL NUMBERS (B)(4), MANUFACTURED IN 02/2011 AND (B)(4) MANUFACTURED IN 01/2011 FAILED OUTPUT TESTING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38468 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other