BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2152970 · Received June 28, 2011

    Report

    Report Number
    3003793371-2011-00024
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS FINLAND OY
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A KNOWN AND PREVIOUSLY REPORTED ISSUE THAT IS CURRENTLY UNDER INVESTIGATION. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILLL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WRONG ENERGY USED FOR DOSE CALCULATION. THE CUSTOMER REPORTS AN ERROR WITH ECLIPSE 10.034 WHEREBY THE ENERGY OF THREE TREATMENT BEAMS OF A PLAN WAS CHANGED FROM 6X TO 10X (BY ECLIPSE NOT THE OPERATOR), YET THE MU, DOSE-DISTRIBUTION (REF. DOSE ETC.), ALL STILL SHOWED THE 6X PLAN INFORMATION. THIS WAS PICKED UP BY THE INDEPENDENT MU CHECK WHICH SHOWED ALL THREE BEAMS WERE OUT OF TOLERANCE AT 5.1%, 7.7% AND 9.5%, WHERE TOLERANCE IS A MAXIMUM 5% DIFFERENCE WITH ECLIPSE. NO SERIOUS INJURY OR MISADMINISTRATION WAS REPORTED.

    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