BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 654760 · Received December 14, 2005

    Report

    Report Number
    1937649-2005-00003
    Event Type
    Malfunction
    Date Received
    December 14, 2005
    Date of Event
    December 2, 2005
    Report Date
    December 14, 2005
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A USER HAD DEVELOPED A TREATMENT PLAN USING THE XIO SOFTWARE AND SWITCHED FROM A COBALT UNIT TO A LINEAR ACCELERATOR. XIO DETECTED AN INVALID TREATMENT DISTANCE, AND THE "DOSE NOT CURRENT" MESSAGE WAS DISPLAYED AT THE BOTTOM OF THE XIO SCREEN, AS WAS APROPRIATE. HOWEVER, WHEN THE USER ENTERED A VALID TREATMENT DISTANCE AND THE MESSAGE WAS REMOVED, XIO DID NOT RECALCULATE THE BEAM, AND THE DOSES FOR THE PREVIOUSLY CALCULATED MACHINE WERE REDISPLAYED. THE PROBLEM WAS DETECTED, AND NO PTS WERE MISTREATED. THIS SAME ISSUE WAS REPORTED UNDER MDR 1937649-2005-002. THIS MDR REPRESENTS A SECOND USER REPORT OF THE SAME SOFTWARE BUG.

    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 4.1.0 - 4.3.0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA