BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 4489060 · Received February 5, 2015

    Report

    Report Number
    1937649-2015-00003
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Report Date
    February 5, 2015
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K102216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. THIS DEFECT WILL BE FIXED IN A LATER VERSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRR IMAGE FILE FOR A DIFFERENT PLAN GOT SAVED IN A PATIENT'S PLAN. XIO IS NOT VERIFYING THE ORIGINAL DOCUMENT NUMBER SAVED IN THE DRR IMAGE FILE WITH THE ORIGINAL DOCUMENT NUMBER SAVED IN THE PLAN FILE BEFORE USING THE DRR IMAGE FILE. THERE WAS NO REPORT OF MISTREATMENT BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83846 XIO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM MUJ IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1