BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 515897 · Received January 26, 2004

    Report

    Report Number
    2914292-2004-00002
    Event Type
    Malfunction
    Date Received
    January 26, 2004
    Date of Event
    December 24, 2003
    Report Date
    January 23, 2004
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO THE VARIAN HELP DESK A SITUATION WHERE A PARTIAL STRUCTURE WAS MISSING AND CONSEQUENTLY COULD HAVE RESULTED IN AN INCORRECT TREATMENT FIELD. THE ORIGINAL CONTACT WAS IN 2003 AND IN A FOLLOW UP DISCUSSION THE CUSTOMER CONFIRMED THAT NO MISTREATMENT OCCURRED. THIS REPORT IS SUBMITTED IN ACCORDANCE WITH 30 DAYS REPORTING GUIDELINES IN THAT ALTHOUGH THE INVESTIGATION IS STILL IN PROCESS THERE IS A REASONABLE PROBABILITY THAT IF THE MALFUNCTION WERE TO RECUR THERE IS A POTENTIAL FOR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS, INC. VER7.1.35 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other