BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAPLAN PLUS

    MDR report key: 570234 · Received April 27, 2004

    Report

    Report Number
    1121753-2004-00001
    Event Type
    Other
    Date Received
    April 27, 2004
    Date of Event
    March 19, 2004
    Report Date
    April 26, 2004
    Manufacturer
    NUCLETRON B.V.
    Product Code
    MUJ
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    UPON DICOM RT PLAN EXPORT OF A PLAN CONTAINING A BEAM FOR WHICH THE BEAM WEIGHT HAS BEEN SET TO ZERO BY THE USER, A NON-ZERO VALUE FOR THE MONITOR UNITS (MU) CAN BE EXPORTED. IN CASE A PLAN CONTAINS A BEAM THAT IS INTENDED AS A SETUP BEAM ONLY AND IT IS NOT INTENDED TO BE USED FOR TREATMENT THE WEIGHT OF THE BEAM IS SET TO ZERO BY THE USER. THE PLAN SPREADSHEET WILL SHOW BEAM WEIGHT 0 FOR THIS BEAM AND N/A FOR THE NUMBER OF MU. UPON EXPORT OF THE PLAN USING DICOM RT PLAN, HOWEVER, THE NUMBER OF MU FOR THE BEAM FOR WHICH THE WEIGHT HAS BEEN SET TO ZERO IS EQUAL TO THE NUMBER OF MU THAT WAS ASSIGNED TO THIS BEAM BEFORE THE USER EDITED THE BEAM WEIGHT TO BE ZERO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPLAN PLUS RADIOTHERAPY TREATMENT PLANNING SYSTEM MUJ NUCLETRON B.V. 3.8 TPP-0837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other