BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 704031 · Received April 20, 2006

    Report

    Report Number
    1937649-2006-00003
    Event Type
    Malfunction
    Date Received
    April 20, 2006
    Date of Event
    March 28, 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 CUSTOMER WAS RUNNING XIO RELEASE 4.3.1 AND CREATING A TREATMENT PLAN THAT INVOLVED A SIEMENS MLC,FFT CONVOLUTION OR SUPERPOSITION ALGORITHM, OPEN FEILD NORMALIZATION AND RELATIVE DOSE MODE.HE REPORTED THAT,IN THE CALCULATION OF OPEN FEILD NORMALIZED POINT DOSE, THE X JAW OF THE MLC WAS IGNORED, CAUSING THE FEILD TO BE LARGER THAN DEFINED BY THE MLC SETTINGS. THE ERROR WAS NOTED,AND NO PATIENTS WERE MISTREATED.WE HAVE RECEIVED NO OTHER REPORTS OF THIS BUG.

    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