BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS RTP SYSTEM

    MDR report key: 477979 · Received August 12, 2003

    Report

    Report Number
    1937649-2003-00003
    Event Type
    Malfunction
    Date Received
    August 12, 2003
    Date of Event
    May 13, 2002
    Report Date
    August 6, 2003
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A CMS EMPLOYEE REPORTED THAT, UNDER CERTAIN CONDITIONS, THE XIO RADIATION TREATMENT PLANNING SYSTEM WAS NOT SAVING USER CHANGES TO FIELD SIZES OF SEGMENTED BEAMS (IMRT TREATMENT PLANS). NO PTS WERE TREATED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM KPQ COMPUTERIZED MEDICAL SYSTEMS, INC. ALL RELEASE 3.2.1

    Patients

    Seq Age Sex Outcome Treatment
    1 *