BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2981328 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00301
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "CONSTANT LOW RUN TIMES ERROR WAS GIVEN DESPITE FOLLOWING PROPER BATTERY MANAGEMENT" COULD NOT BE VERIFIED BECAUSE THE BATTERY WAS NOT RETURNED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE FILED IF THE BATTERY IS RETURNED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONSTANT LOW RUN TIMES ERROR WAS GIVEN DESPITE FOLLOWING PROPER BATTERY MANAGEMENT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36533 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other