BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATO RTS V 1.X

    MDR report key: 92123 · Received May 16, 1997

    Report

    Report Number
    1121753-1997-00022
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Report Date
    May 14, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IYE
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN CERTAIN SPECIFIC SEQUENCES ARE PERFORMED, INCORRECT MU VALUES ARE CALCULATED IN AN ARC ROTATION SETUP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other