BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCENTRA MASTERPLAN

    MDR report key: 1299161 · Received December 4, 2008

    Report

    Report Number
    9611894-2008-00019
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    September 2, 2008
    Report Date
    October 14, 2008
    Manufacturer
    NUCLETRON BV
    Product Code
    MUJ
    PMA / PMN Number
    K081281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OMP BP ADDS A FRACTION AUTOMATICALLY WHILE TRANSFERRING THE PLAN TO ONCENTRA TCS. ONE OF OUR CUSTOMERS USING ONCENTRA BRACHY VERSION 3.1SP1 WITH ONCENTRA TCS VERSION 3.1.2.100 HAS REPORTED A PROBLEM. HE PERFORMED A PLAN AND EXPORTED IT TO THE TCS WITH ONLY (1) ONE FRACTION. FOR SOME REASON HE WANTED TO CHANGE THE NUMBER OF FRACTIONS SO HE COPIED THE PLAN AND CHANGED ONLY THE NUMBER OF FRACTIONS TO 3 AND RE-EXPORTED THE SAME PLAN WITH A DIFFERENT NAME TO TCS. ON IMPORTING THE SECOND STUDY IN THE TCS IT NOW SHOWS THE NUMBER OF FRACTIONS AS (4) FOUR INSTEAD OF 3. THIS PROBLEM COMES ONLY WHEN YOU COPY THE PLAN ON ONCENTRA MASTERPLAN, IF YOU DIRECTLY CHANGE THE NUMBER OF FRACTIONS IN THE SAME PLAN INSTEAD OF COPYING THE PLAN IT IS SHOWING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA MASTERPLAN TREATMENT PLANNING MUJ NUCLETRON BV 3.1

    Patients

    Seq Age Sex Outcome Treatment
    1