BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATO-RTS

    MDR report key: 92113 · Received May 16, 1997

    Report

    Report Number
    1121753-1997-00019
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Date of Event
    March 26, 1997
    Report Date
    May 7, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FOR SOFTWARE PLATO RTS V1.X, INCORRECT MONITOR UNITS ARE CALCULATED IN A MULTIPLE ELECTRON BEAM SET-UP, IN WHICH MANTLE TYPE SHIELDING IS INCLUDED WHEN REFERENCE AXIS ARE IN DIFFERENT LOCATIONS FOR EACH FIELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other