BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR (SHANGHAI)

    MDR report key: 6195752 · Received December 21, 2016

    Report

    Report Number
    1717344-2016-01114
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 2, 2016
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(6) 2016. ONE FORCE FX-CS GENERATOR WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. THE IMPEDANCE WAS SET TO 120 OHMS ON BC GROUP TESTER AND CONNECTED TO THE REM PORT ON UNIT. THE IMPEDANCE WAS INCREASED UNTIL THE REM ALARMED AT 150 OHMS WHICH IS HIGHER THAN THE SERVICE MANUAL SPECIFICATION OF 135+/-5. THE INVESTIGATION ISOLATED THE FAILURE TO THE REM CALIBRATION BEING OUT OF SPECIFICATION, BUT A ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD WAS PERFORMED BY THE (B)(4) MANUFACTURING FACILITY ((B)(4)) WITH NO ENTRIES POTENTIALLY PERTINENT TO THE CUSTOMER'S REPORT NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ROUTINE PREVENTIVE MAINTENANCE THE REM WAS OBSERVED TO BE OUT OF SPECIFICATION FOR A FORCE FX-8CS GENERATOR. THE UNIT WAS RETURNED TO THE SERVICE CENTER WHERE A TECHNICIAN CONFIRMED THE OUT OF SPECIFICATION REM. IMPEDANCE WAS SET TO 120 OHMS ON BC GROUP TESTER, AND CONNECTED TO THE REM PORT ON UNIT. IMPEDANCE WAS INCREASED UNTIL REM ALARMED AT 150 OHMS, HIGHER THAN THE SERVICE MANUAL SPECIFICATION OF 135+-5. PATIENT HARM COULD OCCUR DUE TO THE UNIT NOT ALARMING WHEN IT SHOULD. NO PATIENT INVOLVEMENT OR INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842799 FORCE FX-8C GENERATOR (SHANGHAI) ELECTROSURGICAL GENERATOR GEI COVIDIEN LLC (SHANGHAI)

    Patients

    Seq Age Sex Outcome Treatment
    1