BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 493106 · Received October 28, 2003

    Report

    Report Number
    1937649-2003-00007
    Event Type
    Malfunction
    Date Received
    October 28, 2003
    Date of Event
    October 10, 2003
    Report Date
    October 28, 2003
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A USER REPORTED THAT A DIGITALLY RECONSTRUCTED RADIOGRAPH (DRR) IMAGE, PRINTED DIRECTLY FROM THE SCREEN OF XIO RADIATION TREATMENT PLANNING SYSTEM WAS SCALED IMPROPERLY. THE SYSTEM IS DESIGNED TO EXPAND THE SCREEN IMAGE TO FIT THE WIDTH OF THE PAPER WHILE HOLDING ITS CORRECT ASPECT RATIO. FOR A PARTICULAR DRR, THE XIO RTP SYSTEM OVER EXPANDED THE WIDTH, RESULTING IN THE DRR IMAGE WRAPPING AROUND ON THE LEFT SIDE OF THE PAGE. ONE RESULT OF THIS WAS INCORRECT REPRESENTATION OF PATIENT POSITION RELATIVE TO THE BEAM. THE USER REPORTED ONE PATIENT FOR WHOM THE TREATMENT BEAM HAD BEEN MISALIGNED BY THE AMOUNT THE IMAGE SHIFTED, HOWEVER THE SHIFT IN THIS CASE WAS NOT, IN THEIR JUDGMENT, CLINICALLY SIGNIFICANT.

    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 4.0.0 THROUGH 4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA