BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS RTP SYSTEM

    MDR report key: 179500 · Received July 22, 1998

    Report

    Report Number
    1937649-1998-00005
    Event Type
    Malfunction
    Date Received
    July 22, 1998
    Date of Event
    July 10, 1998
    Report Date
    July 22, 1998
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    WHEN USING A MULTILEAF COLLIMATOR TO FORM A PORT, & CALCULATING DOSE USING THE "FFT" CONVOLUTION ALGORITHM, THE FOCUS RTP SYSTEM IS NOT LOOKING AT THE MULTILEAF COLLIMATOR LEAF POSITIONS TO DEFINE THE PORTAL OUTLINE USED IN DOSE CALCULATION. RATHER, FOCUS IS USING THE ANATOMICAL STRUCTURE OR CUSTOMIZED PORT OUTLINE. THE RESULT COULD BE AN INNOCENT ISODOSE DISTRIBUTION FOR THE CONDITION, WHERE THE MULTILEAF COLLIMATOR PORTAL OUTLINE DOES NOT COINCIDE WITH THE ANATOMICAL STRUCTURE OR CUSTOMIZED PORT OUTLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM MUJ COMPUTERIZED MEDICAL SYSTEMS 9200 RELEASE 1.5.0 & HIGHER

    Patients

    Seq Age Sex Outcome Treatment
    1 *