BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

    MDR report key: 3140144 · Received May 29, 2013

    Report

    Report Number
    8031000-2013-00060
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING SURGERY THAT THE MOTOR DID NOT WORK PROPERLY. IT WAS REPORTED THAT THE DEVICE TURNED ON BUT IT DID NOT RUN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235780 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1