BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS RADIATION TREATMENT PLANNING SYS

    MDR report key: 264620 · Received February 18, 2000

    Report

    Report Number
    1937649-2000-00002
    Event Type
    Malfunction
    Date Received
    February 18, 2000
    Date of Event
    January 20, 2000
    Report Date
    February 18, 2000
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCALING OF DRR PLOTS FOR FOCUS RELEASE 2.5.0 ARE DIFFERENT THAT RELEASE 2.4.0. THE PLOTS ARE LARGER. IF A USER WERE TO CREATE BLOCKS DIRECTLY FROM THE DRR PLOTS, THEY WOULD BE INCORRECT SIZE. IN THIS CASE, 9% LARGER. THE USER FELT THIS COULD RESULT IN EXPOSURE OF A LARGER PT VOLUME THAN PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS RADIATION TREATMENT PLANNING SYS RADIATION TREATMENT PLANNING SYSTEM MUJ COMPUTERIZED MEDICAL SYSTEMS ALL RELEASE 2.5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 *