BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

    MDR report key: 3905227 · Received May 28, 2014

    Report

    Report Number
    8031000-2014-00250
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGERS DO NOT FUNCTION ANYMORE. WITHOUT TOUCHING ANY BUTTON, THE MOTOR IS DIRECTLY TRIGGERING ONCE POWER IS SUPPLIED. THERE WAS NO PATIENT HARM OR DELAY REPORTED. NO ADD'L CLINICAL INFO WAS REC'D PRIOR TO THIS REPORT. IF ADD'L INFO IS REC'D, A F/U MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314819 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T HAB ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1