BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 3970218 · Received April 29, 2014

    Report

    Report Number
    1717344-2014-00336
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    March 31, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT UNIT HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE COVIDIEN REPRESENTATIVE REPORTED THAT MULTIPLE DEVICES ACTIVATE WITH THE REM PAD NOT APPLIED TO ANYTHING, IT WAS JUST LYING ON TOP OF THE UNIT. NO PT PRESENT AND THE UNIT WAS NOT IN DEMO MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256063 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK