BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLETRON PLATO BPS

    MDR report key: 1299165 · Received December 4, 2008

    Report

    Report Number
    9611894-2008-00015
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    July 18, 2008
    Report Date
    October 14, 2008
    Manufacturer
    NUCLETRON BV
    Product Code
    MUJ
    PMA / PMN Number
    K9833343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN JULY 2008, A BULLETIN DESCRIBING THE CONDITION WHEN INCORRECT DOSE VALUES MIGHT BE DISPLAYED WAS DISTRIBUTED TO USERS OF PLATO BPS V14.3 - 14.7.

    Description of Event or Problem · 1

    WHEN CREATING A PLAN IN PLATO BPS VERSION 14.3.3, 14.3.5, 14.3.6, AND 14.3.7 INCORRECT DOSE PERCENTAGES ARE BEING DISPLAYED IN THE POINTS WINDOW WHEN CREATING OF MOVING POINTS IN A CT SLICE. DOSE IN PATIENT POINTS SHOULD BE CORRECTLY CALCULATED AND DISPLAYED IF A PATIENT POINT IS ADDED OR MOVED IN A CT IMAGE. AS A RESULT, PLANS CAN BE INCORRECTLY EVALUATED UNLESS RE-PRESCRIPTION IS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON PLATO BPS TREATMENT PLANNING MUJ NUCLETRON BV 14.3.3 - 14.3.7

    Patients

    Seq Age Sex Outcome Treatment
    1