BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2982196 · Received January 25, 2013

    Report

    Report Number
    3003793491-2013-00138
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    July 26, 2012
    Report Date
    July 26, 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 BATTERY WAS BELOW POWER CRITERIA WAS NOT CONFIRMED BECAUSE THE BATTERY WAS NOT RETURNED FOR INVESTIGATION. CUSTOMER WAS CONTACTED 3 TIMES VIA TELEPHONE AND WAS REQUESTED TO RETURN THE PRODUCT. FIRST ATTEMPT WAS MADE ON (B)(6) 2012, SECOND ATTEMPT WAS MADE ON (B)(6) 2012 AND A FINAL ATTEMPT WAS MADE ON (B)(6) 2012. THE CUSTOMER WAS UNRESPONSIVE TO ALL THREE ATTEMPTS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE BATTERY IS RETURNED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BATTERIES HAVE BEEN FOUND TO BE BELOW POWER CRITERIA DESPITE FOLLOWING PROPER BATTERY MGMT". NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35475 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other