BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 3955503 · Received June 12, 2014

    Report

    Report Number
    1937649-2014-00007
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K102216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IF A RANGE COMPENSATOR IS CREATED PRIOR TO VERSION 5.0 IS ADDED TO A BEAM ON VERSION 5.0, THE COMPENSATOR TYPE IS SET TO UNSMEARED (THE COMPENSATOR DATA IN MEMORY), AND DOSE IS CALCULATED USING UNSMEARED RANGE COMPENSATOR DATA. IF THE PLAN IS SAVED AND RECALLED, XIO WILL CONVERT THE UNSMEARED RANGE COMPENSATOR DATA TO SMEARED (SINCE THE RANGE COMPENSATOR FILE WAS SAVED PRIOR TO RELEASE 5.0), BUT THE DOSE IS NOT RECALCULATED SINCE THE PLAN WAS SAVED ON RELEASE 5.0. ALSO IF A RANGE COMPENSATOR IS CREATED PRIOR TO RELEASE 5.0 IS ADDED TO A BEAM AND THE PLAN IS DICOM EXPORTED, DOSE WILL BE CALCULATED USING UNSMEARED RANGE COMPENSATOR DATA BUT THE DICOM RT ION PLAN FILE THAT IS EXPORTED WILL CONTAIN SMEARED RANGE COMPENSATOR DATA. THEREFORE, THE DOSE ERROR IS THE DIFFERENCE BETWEEN CALCULATING DOSE USING UNSMEARED RANGE COMPENSATOR DATA AND SMEARED RANGE COMPENSATOR DATA. THERE WAS NO ACTUAL MISTREATMENT. THIS ISSUE WAS FOUND INTERNALLY, DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346785 XIO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM MUJ IMPAC MEDICAL SYSTEMS, INC. XIO VERSION 5.00.00

    Patients

    Seq Age Sex Outcome Treatment
    1