BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATO RTS V2.3

    MDR report key: 286730 · Received July 13, 2000

    Report

    Report Number
    1121753-2000-00001
    Event Type
    Malfunction
    Date Received
    July 13, 2000
    Date of Event
    May 23, 2000
    Report Date
    July 6, 2000
    Manufacturer
    NUCLETRON BV
    Product Code
    MUJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN CERTAIN SITUATIONS WHEN ENTERING A BLOCK, THE PROGRAM INTERPRETS THE WHOLE FIELD AS BEING BLOCKED, AND A HIGH NUMBER OF MONITOR UNITS ARE CALCULATED. THE PROBLEM MAY OCCUR WHEN THE BLOCK CONTOUR CONTAINS A LARGE NUMBER OF POINTS AND/OR SOME OF THE POINTS ARE VERY CLOSE TOGETHER. IF THE PROBLEM OCCURS, A WARNING MESSAGE "HIGH ABSOLUTE M.U./MIN. AND/OR HIGH VALUES DETECTED" WILL BE DISPLAYED, AND CALCULATED MONITOR UNITS WILL BE EXCEPTIONALLY HIGH. IF THE WARNING IS IGNORED, UNPLANNED HIGH DOSES COULD BE DELIVERED DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATO RTS V2.3 RADIOTHERAPY TREATMENT PLANNING SYSTEM MUJ NUCLETRON BV RTS V2.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other