BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1624730 · Received February 19, 2010

    Report

    Report Number
    2916710-2010-00011
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 21, 2010
    Report Date
    January 21, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 AN MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE (B)(4) WORKSPACE WOULD PRODUCE DIFFERENT RESULTS FOR A DIGITALIZED BLOCK WHEN THE PT ORIENTATION IS DEFINED AS (B)(4) IN THE PLAN PROPERTIES. NO SERIOUS INJURY TO THE PT WAS REPORTED, AS THIS EVENT WAS OBSERVED DURING TREATMENT PLANNING.

    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