BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 1061127 · Received June 13, 2008

    Report

    Report Number
    1937649-2008-00004
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 16, 2008
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, AN ELEKTA COMPANY
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ADVISORY FOR DETAILS OF THE ISSUE. THE ADVISORY WILL BE SENT TO ALL MONACO CUSTOMERS WORLDWIDE.

    Description of Event or Problem · 1

    WITH THE MONACO RADIATION TREATMENT PLANNING SYSTEM, IF THE USER SELECTS THE MONTE CARLO ALGORITHM FOR FINAL DOSE COMPUTATION, IT IS POSSIBLE THAT THE FINITE SIZE PENCIL BEAM (FSPB) ALGORITHM WILL BE USED INSTEAD. THERE IS NO INDICATION ON THE OUTPUT OF THE SYSTEM THAT THIS HAS OCCURRED WHICH MAY LEAD THE ONCOLOGIST TO MAKE A FALSE ASSUMPTION REGARDING THE ACCURACY OF THE DOSE PRESENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONACO RADIATION TREATMENT PLANNING SYSTEM MUJ COMPUTERIZED MEDICAL SYSTEMS, AN ELEKTA COMPANY REL 1.0.0 - 1.0.2

    Patients

    Seq Age Sex Outcome Treatment
    1