BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 1876595 · Received October 13, 2010

    Report

    Report Number
    2916710-2010-00118
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K050479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS IDENTIFIED A DESIGN DEFICIENCY AT 4D INTEGRATED TREATMENT CONSOLE: INCORRECT DISPLAY OF A FIELD CIAO (COMPLETE IRRADIATED AREA OUTLINE) IN 4DITC. IT ONLY HAPPENS IN CASE OF AD-HOC IMAGING. THE 4DITC'S CALCULATION FOR AD-HOC IMAGE TEMPLATE - THIS ISSUE IS RELATED TO INCORRECT CIAO DISPLAYED FOR IMAGING FIELD AND IN TURN THIS MAKES MLC LEAF POSITIONS GO AS PER THE CIAO AND IN TURN THIS MAKES THE IMAGE TAKEN AS PER CIAO. IF ELECTRON FIELDS ARE ABUTTED TO CIAO, THE RESULTING ELECTRON FIELD WOULD BE TOO SMALL, WHICH WILL LEAD TO UNDER DOSE OF TARGET VOLUME. STANDARD RADIATION THERAPY PRACTICE INCLUDES ROUTINE PT SETUP AND PLANNED ISOCENTER/TREATMENT VOLUME VERIFICATION PRIOR TO TREATMENT DELIVERY REGARDLESS OF DOCUMENTED PT PLAN SETUP INSTRUCTIONS. THIS VERIFICATION CAN BE DONE THROUGH THE USE OF MV, KV IMAGING OR USE OF FILM PRIOR TO PT TREATMENT. IN ADDITION, CLINICAL VISUALIZATION OF THE ELECTRON BLOCK MATCH - USER WOULD HAVE TO GO INSIDE ROOM AND PERFORM MANUAL MATCH. THIS USE CASE IS LIMITED TO ONLY AD-HOC IMAGING AND ELECTRON ABUTTING TREATMENT. NO PT INJURY REPORTED. A CUSTOMER TECHNICAL BULLETIN WILL BE SENT TO AFFECTED CUSTOMERS TO PROVIDE CLARIFICATION AND FURTHER INSTRUCTIONS REGARDING THIS ISSUE. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    MIDLINE BAR ON FIELD APPEARS INCORRECT WHEN IMAGED. THE FOLLOWING WAS REPORTED: MLC GRAPHICAL DISPLAY IS CORRECT WHEN FIELD IS MODED UP FOR TREATMENT. UPON ADDING A "BEFORE PLANNED" IMAGE TEMPLATE, THE MLC FIELD GRAPHIC DISPLAY IS NO LONGER ACCURATE. IT APPEARS A PORTION OF THE MLB IS MISSING AND C-SPINE IS NOT BLOCKED AS PLANNED. THE CUSTOMER VERIFIED THAT THE ANOMALOUS DISPLAY OCCURS ONLY DURING IMAGING. TREATMENT IS NOT AFFECTED. THERE WAS NO REPORT OF INJURY TO THE PT AND NO PT DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE LINEAR ACCELERATOR SOFTWARE IYE VARIAN MEDICAL SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1