BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEFX-8C GENERATOR

    MDR report key: 4259677 · Received November 18, 2014

    Report

    Report Number
    1717344-2014-01002
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    July 14, 2014
    Report Date
    November 11, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION FOUND THE CAUSE OF THE REM FAILURE TO BE THE UNIT'S REM MONITORING SYSTEM REQUIRED CALIBRATION. THE FORCE FX-8C SERVICE MANUAL PROVIDES A CALIBRATION PROCEDURE WHICH INCLUDES REM. IN ADDITION, A TEST PROCEDURE IS PROVIDED TO PERFORM A SAFETY CHECK EVERY 6 MONTHS TO ENSURE THE GENERATOR IS FUNCTIONING PROPERLY WHICH INCLUDES REM TESTING. THE GENERATOR WAS FULLY CALIBRATED AND TESTING FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER HAD REPORTED THAT THE UNIT FAILED REM TESTING. INITIAL EVALUATION OF THE UNIT FOUND THE REM TRIP POINT OF 135 OHMS +/-5 TRIPPED HIGHER THAN THE MAXIMUM VALUE OF 140 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746304 FORCEFX-8C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP FORCEFX-8C

    Patients

    Seq Age Sex Outcome Treatment
    1