BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 704013 · Received April 20, 2006

    Report

    Report Number
    1937649-2006-00004
    Event Type
    Malfunction
    Date Received
    April 20, 2006
    Date of Event
    April 6, 2006
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE USER WAS EXPORTING TREATMENT PLAN INFORMATION FROM OUR XIO RTP SYSTEM, RUNNING RELEASE 4.3.1,TO A VARIS R & V SYSTEM.THE USER NOTICED THAT WEDGES WERE NOT BEING EXPORTED TO THE VARIS SYSTEM CORRECTLY.THE ERROR WAS DETECTED,AND NO PATIENTS WERE MISTREATED. THIS PROBLEM WAS ALSO REPORTED BY ANOTHER XIO USER (SEE MDR 1937649-2006-002).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM KPQ COMPUTERIZED MEDICAL SYSTEMS, INC. ALL 4.3.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA