BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR (SHANGHAI)

    MDR report key: 5830895 · Received July 28, 2016

    Report

    Report Number
    3006451981-2016-00302
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    June 16, 2016
    Report Date
    June 16, 2016
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    PMA / PMN Number
    K944602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF THIS REPORT: 07/28/2016. ONE USED FORCEFXCS WAS RECEIVED FOR EVALUATION. THE CUSTOMER REPORTED REM ERROR DURING TESTING. THE INVESTIGATION FOUND THE GENERATOR'S REM VOLTAGE WAS OUT OF SPECIFICATION. THE GENERATOR ALSO FAILED REM TRIP POINT TESTING. THE INVESTIGATION ISOLATED THIS FAILURE TO THE REM VOLTAGE. THE GENERATOR'S PEAK TO PEAK REM VOLTAGE WAS SET TO SPECIFICATION TO ADDRESS THE CONDITION. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD WAS PERFORMED AND NO ENTRIES POTENTIALLY PERTINENT TO THE CUSTOMER¿S REPORT WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A REM ERROR DURING TESTING OF A USED FORCEFXCS GENERATOR. NO PATIENT WAS PRESENT. INITIAL EVALUATION OF THE UNIT CONFIRMED THE CUSTOMER'S REPORT OF A REM ERROR. THE INVESTIGATION FOUND THE GENERATOR'S REM VOLTAGE WAS OUT OF SPECIFICATION (LOW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482233 FORCE FX-8C GENERATOR (SHANGHAI) ELECTROSURGICAL GENERATOR GEI COVIDIEN LLC (SHANGHAI)

    Patients

    Seq Age Sex Outcome Treatment
    1