BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCAL WORKSTATION

    MDR report key: 490285 · Received October 14, 2003

    Report

    Report Number
    1937649-2003-00006
    Event Type
    Malfunction
    Date Received
    October 14, 2003
    Date of Event
    July 16, 2003
    Report Date
    October 14, 2003
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    LMD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CMS EMPLOYEE CREATED A TREATMENT PLAN USING CMS'S XIO RTP SYSTEM, THEN SENT THE PLAN TO FOCAL. THE PLAN USED SSD (SOURCE-TO-SKIN DISTANCE) BEAMS. FOCAL MISINTERPRETED WHERE THE FIELD SIZE WAS DEFINED, RESULTING IN A GRAPHIC DISPLAY OF THE SSD BEAMS THAT DID NOT REFLECT THE CORRECT FIELD SIZED OR DIVERGENCES. THIS PROBLEM HAS NOT BEEN REPORTED BY ANY CUSTOMER, AND NO PTS HAVE BEEN MISTREATED AS A RESULT OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCAL WORKSTATION RADIATION TREATMENT PLANNING SYSTEM LMD COMPUTERIZED MEDICAL SYSTEMS, INC. ALL RELEASES 4.0.2 THROUGH 4.1.0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA