BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 929288 · Received October 16, 2007

    Report

    Report Number
    1717344-2007-00356
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    September 18, 2007
    Report Date
    September 18, 2007
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 10/16/2007. THE GENERATOR IS CURRENTLY UNDER EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    INITIALLY, THE UNIT WAS RETURNED FOR SERVICE FOR "NO OUTPUT". DURING THE CALIBRATION IN OUR SERVICE DEPARTMENT, IT WAS DISCOVERED THAT THE GENERATOR "LATCHED ON" INDICATING IT CONTINUOUSLY DELIVERED OUTPUT ONCE THE OUTPUT WAS ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI VALLEYLAB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR