BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 486843 · Received September 26, 2003

    Report

    Report Number
    1937649-2003-00005
    Event Type
    Malfunction
    Date Received
    September 26, 2003
    Date of Event
    August 15, 2003
    Report Date
    September 25, 2003
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE USER (A CO EMPLOYEE) ADDED A WEDGE TO A BEAM AND RECEIVED AN ERROR MESSAGE STATING THAT THE WEDGE DID NOT COVER THE TREATMENT FIELD. AFTER ACKNOWLEDGING THE MESSAGE, THE USER NOTED THAT THE WEDGE HAD BEEN REMOVED FROM THE BEAM, AND THE DOSE HAD NOT BEEN RECOMPUTED. NO PTS WERE MISTREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM MUJ COMPUTERIZED MEDICAL SYSTEMS, INC. ALL RLEASES 4.0.0 THROUGH 4.1.0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA