BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1845045 · Received September 13, 2010

    Report

    Report Number
    3003793371-2010-00014
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION 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. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DISPLAY OF ISOCENTER ON DRR MOVES WHEN DRR SIZE IS REDUCED. THE CUSTOMER REPORTED THAT THEY CREATED A DRR ON AP BEAM OF PATIENT (GANTRY = 0), MOVED THE BEAM TO THE LEFT ON PATIENT AND THE DRR RECALCULATED AS EXPECTED. (THE DEFAULT SIZE OF DRR'S IS 50 CM AND THIS IS EDITABLE IN THE DRR OPTIONS DIALOGUE BOX.) USER THEN SELECTED THE OPTION TO DECREASE THE SIZE OF THE DRR THEN THE DISPLAY OF THE DRR SHOWED THE FIELD TO BE MOVED, EACH REDUCTION OF THE DRR SIZE RESULTED IN A FURTHER MOVE OF THE FIELD / ISOCENTER DISPLAY ON THE DRR TO THE RIGHT. NOTE - THIS DID NOT HAPPEN IF THE BEAM WAS LOCATED ON THE RIGHT SIDE OF THE PATIENT. DRR WAS ALSO CREATED FOR THE LATERAL BEAM AND REDUCED AND NO PROBLEMS WERE DETECTED. NO PATIENT INJURY REPORTED, AND NO PATIENT DATA PROVIDED. THE DISCREPANCY WAS CAUGHT PRIOR TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS H48-ECLIPSE DX

    Patients

    Seq Age Sex Outcome Treatment
    1