BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 523607 · Received February 16, 2004

    Report

    Report Number
    1937649-2004-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2004
    Date of Event
    November 27, 2003
    Report Date
    February 16, 2004
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE SOURCE INDEX FOR THE SAME TREATMENT PLAN, WHEN PRINTED ON TWO DIFFERENT DATES, REPORTED DIFFERENT VALUES FOR THE OFFSET OF THE BEAM ENTRY POINT FROM THE SETUP REFERENCE POINT. NO PTS WERE MISTREATED AS A RESULT OF THIS PROBLEM.

    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 RELEASES 2.1.0 THROUGH 4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA