BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIMATRON DIGITAL IMAGING

    MDR report key: 869582 · Received June 21, 2007

    Report

    Report Number
    8020711-2007-00002
    Event Type
    Malfunction
    Date Received
    June 21, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 10, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    PMA / PMN Number
    K851653
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRELIMINARY EVALUATION, A SOFTWARE CODE MALFUNCTION WAS IDENTIFIED IN XIMAVISION/XIMATRON DIGITAL IMAGING V7.5.51.6 SP2. TESTS HAVE CONFIRMED THAT ONLY THIS VERSION (SP2) OF DIGITAL IMAGING IS AFFECTED. A SOLUTION TO THIS SOFTWARE ANOMALY IS CURRENTLY UNDER DEVELOPMENT BY VARIAN MEDICAL SYSTEMS, AND WILL BE PROVIDED TO AFFECTED CUSTOMERS UPON RELEASE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT TREATMENT PLAN NO LONGER DISPLAYED ACCESSORIES SUCH AS DYNAMIC WEDGE, STANDARD WEDGE OR BLOCK AFTER XIMATRON DIGITAL IMAGES WERE ACQUIRED. THEY REPORTED THAT THE PLAN LOSES THE ACCESSORIES FOR THE FIELD IF THERE IS NO MULTI-LEAF COLLIMATOR (MLC) ATTACHED TO A FIELD IN THE PLAN. IF THE PAN DOES HAVE AN MLC ATTACHED TO A FIELD THEN NO PROBLEMS ARE OBSERVED. THIS ANOMALY WAS DETECTED BY THE USER PRIOR TO TREATMENT, AND NO MISTREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIMATRON DIGITAL IMAGING ONCOLOGY INFORMATION SYSTEM KPQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR