BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD

    MDR report key: 4071071 · Received August 29, 2014

    Report

    Report Number
    4071071
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ESU WAS BEING PREPARED TO BE USED AND HAD AN E275 ERROR MESSAGE. NOTE FROM BIOMED TECHNICIAN "TURNED UNIT ON SELF TEST PASSES. ERROR LOG STATES 3 ERRORS FROM THIS MORNING. CALLED COVIDIEN AND FOUND OUT THAT 1 OF THE 3 ERRORS IS A CRITICAL ERROR THAT THEY ARE AWARE OF. I AM GOING TO SEND THIS UNIT IN FOR REPAIR AND GET A LOANER IN THE MEANTIME. PACKAGED THE UNIT UP FOR SHIPMENT AND WILL DELIVER TO FED EX DROP OFF ZONE.RMA# 8853825".======================MANUFACTURER RESPONSE FOR ESU, FORCE TRIAD (PER SITE REPORTER).======================MANUFACTURER HAS ISSUED A RMA AND WILL EVALUATE AND REPAIR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527879 FORCETRIAD GENERATOR, ELCTROSURGICAL UNIT GEI COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON OF TYCO HEALTHCARE FORCE TRIAD *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NOT TO MY KNOWLEDGE.