BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS

    MDR report key: 279814 · Received May 23, 2000

    Report

    Report Number
    1937649-2000-00006
    Event Type
    Malfunction
    Date Received
    May 23, 2000
    Date of Event
    November 19, 1999
    Report Date
    May 19, 2000
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    ON THE FOCUS RTP SYSTEM, UNDER CERTAIN CONDITIONS, WHEN THE USER HAS AN "SPV" IN ONE SUBWINDOW, THE GLOBAL MAXIMUM DOSE FIGURE WILL BE INCORRECTLY REPORTED FOR ONE PARTICULAR PT SLICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS RADIATION TREATMENT PLANNING SYSTEM KPQ COMPUTERIZED MEDICAL SYSTEMS ALL RELEASE 2.4.0

    Patients

    Seq Age Sex Outcome Treatment
    1 *