BEUDAMED
    FDA Adverse Event Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 2468922 · Received February 16, 2012

    Report

    Report Number
    2916710-2012-00008
    Date Received
    February 16, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    IYE
    PMA / PMN Number
    K001643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS REPRODUCED. SAFETY ANALYSIS: THE TREATMENT FIELD IS NOT IMPACTED; TREATMENT FIELDS WORK WITHOUT ANY ISSUES. THIS IS AN ISSUE WITH THE AD-HOC IMAGE TEMPLATE. THE 4DITC AD-HOC CIAO (COMPLETE IRRADIATED AREA OUTLINE) CALCULATION RESULTS IN AN ERROR THAT WILL BE PRESENT IN THE 4DITC MLC DISPLAY. IF THE CIAO IMAGE GENERATED BY 4DITC IS PROJECTED ON THE PT USING THE LIGHT FIELD, THE INCORRECT FIELD EDGE WILL BE DISPLAYED. IF THE FIELD EDGE IS USED FOR SET-UP OF ANOTHER ABUTTING TREATMENT FIELD, THE AREA BETWEEN THE PROJECTED FIELD EDGE AND THE ABUTTING FIELD EDGE WOULD BE MISMATCHED AND NOT TREATED. THE MOST SERIOUS PROBABLE SCENARIO WOULD BE AN UNDER-DOSE OF THE PRESCRIBED AREA OF TREATMENT VOLUME. AN UNDER-DOSE CARRIED OUT FOR THE ENTIRE COURSE OF TREATMENT COULD LEAD TO LOSS OF TUMOR CONTROL AND POTENTIAL TUMOR SPREAD WHICH MIGHT LEAD TO REOCCURRENCE OR SPREAD. (B)(4). NO FURTHER F/U TO THIS MDR IS ANTICIPATED. (B)(4).

    Description of Event or Problem · 1

    AT THE TIME OF FILM ACQUISITION, MLC SHAPE WAS DIFFERENT FROM PLAN. THE RADIATION TECHNOLOGIST OPENED A PLAN IN 4D INTEGRATED TREATMENT CONSOLE (4DITC), AND MODED UP THE FIELD OF THE FILM. THE MLC DISPLAY ON 4DITC WAS DIFFERENT FROM THE MLC SHAPE IN THE PLAN. WHEN THE FILM IS ADDED IN SCHEDULING OF RT CHART, THIS PROBLEM DOES NOT OCCUR. WHEN ADD FILM IN 4DITC IS USED, A PROBLEM OCCURS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1