BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2190603 · Received July 27, 2011

    Report

    Report Number
    3003793371-2011-00034
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS FINLAND OY
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THEY CREATED A TREATMENT PLAN IN WHICH THEY MEASURED MANY SMALL FIELDS WITH DIFFERENT MLC SHAPES USED FOR STEREOTACTIC APPLICATION. WHEN VERIFYING THE DOSE CALCULATED BY ECLIPSE WITH MEASUREMENTS, THE CUSTOMER FOUND LARGE DOSE DISAGREEMENTS. THERE WAS NO REPORT OF SERIOUS INJURY OR MISADMINISTRATION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE SYSTEM, PLANNING, RADIATION THERAPY TREAT MUJ VARIAN MEDICAL SYSTEMS FINLAND OY H48

    Patients

    Seq Age Sex Outcome Treatment
    1