BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 4135670 · Received October 2, 2014

    Report

    Report Number
    1717344-2014-00867
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Report Date
    September 23, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE WAS RECEIVED AND THE INVESTIGATION FOUND THE REM FUNCTION TO BE MALFUNCTIONING. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THIS FAILURE TO BE CAPACITORS C 165 AND C 209 ON THE RF BOARD. THE RF BOARD WAS REPLACED TO CORRECT THE PROBLEM, AND THE APPROPRIATE UPGRADES WERE IMPLEMENTED. THE GENERATOR WAS CALIBRATED AND TESTING FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    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 CUSTOMER REPORTED THAT A REM COMPONENT FAILED.INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE'S REM INDECATOR LIGHT IS GREEN WHEN NOTHING IS PLUGGED IN. REM ALARMS WHEN A REM BOX IS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614951 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP FORCETRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1