BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 6949509 · Received October 13, 2017

    Report

    Report Number
    1717344-2017-06067
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    July 26, 2017
    Report Date
    September 26, 2017
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    PMA / PMN Number
    K944602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE USED FORCEFX-8CS GENERATOR WAS RECEIVED, AND EXAMINATION OF THE SAMPLE CONFIRMED AN ISSUE WITH THE REM ALARM SYSTEM. TESTING OF THE DEVICE FOUND THE UPPER REM RANGE IS EXCEEDED BEFORE THE DEVICE WILL ALARM. THE INVESTIGATION ISOLATED THE ISSUE TO THE CALIBRATION OF THE REM, BUT A ROOT CAUSE COULD NOT BE IDENTIFIED. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE REM WAS CALIBRATED TO ADDRESS THE CONDITION."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAD AN REM ISSUE. THE ALARM SYSTEM WAS OUT OF RANGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727237 FORCE FX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FORCEFXC

    Patients

    Seq Age Sex Outcome Treatment
    1