BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 6086006 · Received November 8, 2016

    Report

    Report Number
    1717344-2016-01034
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    October 27, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    PMA / PMN Number
    K110268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT: 11/8/2016. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION ISOLATED THE FAILURE TO THE REM NEEDING CALIBRATION, BUT A ROOT CAUSE WAS NOT IDENTIFIED. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE REM WAS CALIBRATED TO ADDRESS THE CONDITION. NO TREND HAS BEEN IDENTIFIED. NO CORRECTIVE ACTION IS REQUIRED, BECAUSE NO TREND HAS BEEN IDENTIFIED. A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORDS INDICATE REWORK PERFORMED ON THIS SERIAL NUMBER IS NOT RELATED TO THIS EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A REM CIRCUIT ISSUES. THE INITIAL INVESTIGATION FOUND THAT THE REM INDICATOR IS GREEN IMMEDIATELY ON START UP, AND THE UNIT CAN BE KEYED WITHOUT ANYTHING HOOKED UP TO THE REM PORT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736316 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1