BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 736341 · Received June 24, 2005

    Report

    Report Number
    1717344-2005-00092
    Event Type
    Malfunction
    Date Received
    June 24, 2005
    Report Date
    May 31, 2005
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 6/23/2005.

    Description of Event or Problem · 1

    REPORTEDLY, THERE WAS A FIRE DURING A CASE. THE DETAILS OF WHICH HAVE NOT BEEN MADE AVAILABLE. THE FACILITY STATED THEY WILL NOT RELEASE ANY EVENT DETAILS BECAUSE OF HIPAA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN E2450H ELECTROSURGICAL HANDPIECE.| E7507 PT RETURN ELECTRODE.