BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT

    MDR report key: 3172262 · Received June 5, 2013

    Report

    Report Number
    8031000-2013-00078
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER HANDPIECE STOPPED WORKING. THE BATTERY PACK WAS TAKEN OFF FOR A HARD RESET MULTIPLE TIMES AND WAS NO LONGER FUNCTIONAL. SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PT INJURY, MEDICAL/SURGICAL INTERVENTION OR SURGICAL DELAY ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249522 UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT UNIVERSAL BATTERY FOR ASEPTIC TRANSFER KIT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1