BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3831994 · Received March 7, 2014

    Report

    Report Number
    8031000-2014-00120
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    ZIMMER SURGICAL S.A. CHEMIN PRE FLEURI 3
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURND TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE STOPPED WORKING DURING PROCEDURE. THE ACCOUNT TRIED DISCONNECTING THE BATTERY FOR A RESET. THEN TRIED A DIFFERENT (NEW) BATTERY. THE DEVICE WOULD NOT WORK. THEY ALLOWED THE DEVICE TO COOL DOWN FOR A BIT AND RE-TRIED, THE DEVICE STILL WOULD NOT WORK. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138672 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GEY ZIMMER SURGICAL S.A. CHEMIN PRE FLEURI 3 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1