BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3770287 · Received February 18, 2014

    Report

    Report Number
    8031000-2014-00081
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 21, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED 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 HANDPIECE FAILED. THE STAFF INVOLVED INT HE CASE REPORTED THA THE HCP ATTEMPTED TO RESET THE BATTERY WHICH DDI NOT RESUME HANDPIECE FUNCTION. IT WAS REPORTED THA THE INCIDENT DID NOT NEGATIVELY AFFECT THE PATIENT OR THE PROCEDURE. ZIMMER UNIVERSAL POWER EQUIPMENT (ZUPE) SETS/KITS CONTAIN MULTIPLE BATTERY POWER SOURCES FOR AVAILABLE USE/SUBSTITUTE AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101846 UNVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GEY ZIMMER SURGICAL S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1