BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2666675 · Received July 13, 2012

    Report

    Report Number
    3003793371-2012-00008
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Date of Event
    June 14, 2012
    Report Date
    June 14, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A MALFUNCTION IN THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A PROBLEM WITH ASSIGNING A CT VALUE TO A STRUCTURE IN ECLIPSE 10.0.39. THE CUSTOMER HAS A PHANTOM AND HE WOULD LIKE TO ASSIGN A CT VALUE TO A PORTION OF IT. THIS PART HE HAS CALLED "CONTRAST". WHAT HE HAS NOTICED IS THAT IF HE ASSIGNS THE CT VALUE OF 0 IN THE CONTOURING WORKSPACE, THIS HAS NO EFFECT ON HIS DOSE CALCULATION. THE MU OF HIS PLAN IS THE SAME AS IF HE HAD NOT ASSIGNED THE CT VALUE (MU = 1012). HOWEVER, IF HE GOES TO THE EXTERNAL BEAM WORKSPACE AND ASSIGNS THE CT VALUE THERE HE DOES SEE THE EXPECTED EFFECT ON HIS MU (MU = 1002). ACCORDING TO THE REPORT, THERE WAS NO PT INJURY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM SYSTEM, PLANNING, RAD, THERAPY TREATMENT MUJ VARIAN MEDICAL SYSTEMS, INC. H48

    Patients

    Seq Age Sex Outcome Treatment
    1