BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2025837 · Received February 16, 2011

    Report

    Report Number
    3003793371-2011-00002
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS THE POTENTIAL FOR THE USER TO UNKNOWINGLY SHIFT THE PT TO THE WRONG LOCATION FOR THE TREATMENT. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY ALLOW THE USER TO UNKNOWINGLY SHIFT THE PT TO THE WRONG LOCATION FOR TREATMENT RESULTING IN MISTREATMENT AND SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER "PLAN APPROVED" A BOOST PLAN, THEN CREATED A BOOST VERIFICATION PLAN. UPON EXPORT OF THE VERIFICATION PLAN, THEY REC'D A WARNING: "DELTA COUCH SHIFTS FROM THE USER ORIGIN DIFFER FROM THE CALCULATED VALUES FOR THE FOLLOWING FIELDS". BECAUSE THE "SHOW DELTA COUCH EDITOR UPON PLAN APPROVAL" OPTION HAD BEEN DE-SELECTED IN ADMINISTRATION, THE DELTA COUCH EDITOR AND THEREFORE THE DELTA COUCH SHIFT (DCS) WARNING MESSAGE, IS NOT DISPLAYED DURING PLAN APPROVAL. THE USER WAS UNAWARE THAT THE DELTA COUCH SHIFTS WERE COPIED WITH THE PASTED PLAN. ONLY UPON EXPORT OF THE VERIFICATION PLAN DID THE USER BECOME AWARE. IF YOU ATTEMPT TO TREATMENT APPROVE THE PLAN, A PLAN VALIDATION IS FORCED AND YOU ARE GIVEN A SAME WARNING. THE USER WAS CONCERNED BECAUSE THE USER IS NOT AWARE THAT THE DCS VALUES ARE BEING TRANSFERRED WITH THE COPIED PLAN. THEY FELT THESE VALUES SHOULD EITHER BE CLEARED OR THE USER SHOULD BE WARNED UPON PLAN APPROVAL, NOT JUST TREATMENT APPROVAL. UNAPPROVED PLANS DO NOT RECEIVE A WARNING AT EXPORT, ONLY APPROVED PLANS. THE PLAN PRINTOUT WILL DISPLAY THE INVALID SHIFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM SYSTEM,PLANNING,RADIATION THERAPY TREAT MUJ VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS H48B

    Patients

    Seq Age Sex Outcome Treatment
    1