BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATO RTS

    MDR report key: 84367 · Received April 14, 1997

    Report

    Report Number
    1121753-1997-00007
    Event Type
    Malfunction
    Date Received
    April 14, 1997
    Date of Event
    March 13, 1997
    Report Date
    April 9, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    ISODOSE DISTRIBUTION IS SHIFTED WHEN THE GRID SIZE IS CHANGED AND ELECTRON BEAMS ARE USED OR WHEN GRID SIZE IS CHANGED AND ELECTRON AND PHOTON BEAMS ARE USED IN COMBINATION. IOSDOSE DISTRIBUTION IS NOT SHIFTER WHEN THE GRID IS CHANGED AND PHOTON BEAMS ALONE ARE USED. THE PROBLEM ONLY OCCURS IS THE FOLLOWING SEQUENCE IS USED: (1) SETUP BEAMS EITHER ELECTRON OR ELECTRON PLUS PHOTON, (2) CALCULATE ALL PANES AND 3) CHANGE THE GRID SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATO RTS RADIOTHERAPY TREATMENT PLANNING SYSTEM IWB NUCLETRON CORP. PLATO RTS V. 1.5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other