BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2972092 · Received January 22, 2013

    Report

    Report Number
    3003793491-2012-00431
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "BATTERY FAULTY" COULD NOT BE VERIFIED BECAUSE THE BATTERY WAS NOT RETURNED FOR INVESTIGATION. IN ORDER TO GET THE BATTERY BACK, ZOLL CONTACTED THE CUSTOMER A TOTAL OF 8 TIMES. FIVE TIMES VIA EMAIL, (FEBRUARY 13, MARCH 30, MAY 2, MAY 24, JUNE 29). FURTHERMORE, TWO ATTEMPTS BY ZOLL REP, AND A FINAL ATTEMPT BY ZOLL (B)(4) WERE MADE, BUT TO NO AVAIL. CUSTOMER'S LAST RESPONSE WAS THAT THEY WERE NOT ABLE TO LOCATE THE BATTERIES. A SUPPLEMENTAL REPORT WILL BE FILED IF THE BATTERIES ARE RETURNED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON SHIFT CHECK, THE UNIT SHOWED "BATTERY FAULTY" MESSAGE ON THE DISPLAY. BATTERY DID NOT PASS ON THE EXTERNAL CHARGERS. CUSTOMER HAS RECORDS OF MONTHLY TEST CYCLES AND THE BATTERIES ARE LESS THAN A YEAR OLD. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32050 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other