BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1760690 · Received July 14, 2010

    Report

    Report Number
    3003793371-2010-00010
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. 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

    THE CUSTOMER REPORTED THAT DURING COMMISSIONING OF THE REFERENCE EQUIPMENT, IT WAS REPORTED THAT WHILE CONFIGURING A 60 DEGREE HARD WEDGE FOR A VARIAN NOVALIS TX MACHINE (BOTH FOR 6X AND 18X ENERGY MODES), AND CALCULATING THE DOSE IN BEAM ANALYSIS, THE CALCULATION DEVIATED SIGNIFICANTLY FROM THE MEASUREMENT. THIS DEVIATION WAS CONSIDERED UNACCEPTABLY LARGE AND THE 60 DEGREE WEDGE WAS DISABLED SO THAT IT CANNOT BE USED FOR CLINICAL PLANS. THE DEVIATIONS BETWEEN MEASUREMENT AND CALCULATIONS WERE UP TO 10%, THE LARGEST DEVIATIONS OCCURRING IN THE HIGH DOSE END OF THE WEDGE PROFILES. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED, AS THE USER OBSERVED THIS EVENT DURING EQUIPMENT COMMISSIONING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1