BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 704810 · Received April 20, 2006

    Report

    Report Number
    1937649-2006-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2006
    Date of Event
    March 30, 2006
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE USER HAD MULTIPLE DRRS TO PRINT, AND OFFSETS WERE SPECIFIED. THE FIRST DRR PRINTED CORRECTLY, BUT IN SUBSEQUENT DRRS, THE ANATOMY AND BEAM WERE OFFSET BUT NOT THE CT IMAGE. THE USERS NOTICED THE ERROR AND REPORTED THE PROBLEM. NO PT WERE MISTREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM IYE COMPUTERIZED MEDICAL SYSTEMS, INC. ALL 4.3.0 - 4.3.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA