BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 371906 · Received January 18, 2002

    Report

    Report Number
    1124791-2002-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2002
    Date of Event
    December 21, 2001
    Report Date
    December 21, 2001
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MVJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INTERNAL EMPLOYEE OF VARIAN MEDICAL SYSTEMS BECAME AWARE OF A ANECDOTAL REPORT OF A SOFTWARE ANOMALY IN THE ECLIPSE TREATMENT PLANNING SOFTWARE FROM AN OVERSEAS DISTRIBUTOR LOCATED IN JAPAN. THE ANOMALY WAS DISCOVERED DURING ACCEPTANCE TESTING OF A NEW ECLIPSE INSTALLATION. ECLIPSE SOFTWARE SUPPORTS A TECHNIQUE KNOWN AS DYNAMIC CONFORMAL ARC. THIS ALLOWS ECLIPSE TO COMBINE ROTATIONAL ARCING FIELD TECHNIQUES WITH A DYNAMIC MLC. ECLIPSE WILL ALLOW UP TO 99 SEGMENTS TO BE DESIGNATED FOR AN ARC FIELD WITHOUT THE USE OF A DYNAMIC MLC. A DYNAMIC MLC HAS THE ABILITY TO DESIGNATE UP TO 500 ARC SEGMENTS. IF MORE THAN 99 SEGMENTS ARE ENTERED FOR AN ARC TREATMENT IN THE DYNAMIC MLC'S PROPERTIES WINDOW, IT WILL CAUSE AN OVERFLOW CONDITION IN THE DOSE CALCULATION ENGINE OF ECLIPSE THAT RESULTS IN ERRONEOUS PLAN NORMALIZATION AND SUBSEQUENTLY CAUSES INCORRECT MU'S TO BE COMPUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SOFTWARE MVJ VARIAN MEDICAL SYSTEMS NA VERSION 6.5 BUILD 7.0.19

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other