BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 6416875 · Received March 20, 2017

    Report

    Report Number
    1717344-2017-05114
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 22, 2017
    Report Date
    February 22, 2017
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    PMA / PMN Number
    K944602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE NON-REM TRIP POINTS FAILED. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION FOUND RED REM RECEPTACLE WIRES ATTACHED TO THE DISPLAY BOARD. THE RED REM WIRES SHOULD BE ATTACHED TO THE PSRF BOARD AT HEADER J15. THE INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE OR A PROBABLE ROOT CAUSE FOR THE CUSTOMER'S REPORT BASED ON THE INFORMATION PROVIDED. THE REM RECEPTACLE WIRE WAS CONNECTED CORRECTLY TO ADDRESS THE CONDITION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT REPORTED THAT DURING TESTING THE NON-REM TRIP POINTS FAILED. THE REM INDICATOR LAMP SHOULD ILLUMINATE RED WHEN A NON-REM PLUG IS INSERTED. THE REM LAMP ILLUMINATED GREEN WITH A NON-REM PLUG INSERTED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200689 FORCE FX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FORCEFXC

    Patients

    Seq Age Sex Outcome Treatment
    1