BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4DITC

    MDR report key: 1993577 · Received January 24, 2011

    Report

    Report Number
    2916710-2011-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    November 2, 2010
    Report Date
    January 14, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC, ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION HAS BEEN CONFIRMED. PLAN EDIT SETTINGS MALFUNCTIONED; UNINTENDED GANTRY ANGLES ARE BEING ACQUIRED. THIS IS A KNOWN ISSUE AND HAS BEEN PREVIOUSLY REPORTED. NO SERIOUS INJURY OR MISADMINISTRATION OCCURRED IN THIS CASE, HOWEVER, A CAPA HAS BEEN INITIATED AND FURTHER ACTIONS ARE ADDRESSED IN VARIAN'S CAPA PROCESS. IN ADDITION, AN URGENT MEDICAL DEVICE CORRECTION NOTIFICATION WAS SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTIONS HAVE BEEN REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADD'L F/U TO THIS REPORT IS EXPECTED.

    Description of Event or Problem · 1

    PLAN EDIT SETTINGS MALFUNCTIONED. ON (B)(6) 2010, CUSTOMER EXPERIENCED AN UNEXPECTED PLAN REVISION CAUSED BY THE MACHINE. A SHIFT FOR COUCH RTN OCCURRED ALONG WITH LINEAR PARAMETERS. EDITING COUCH RTN TRIGGERED A NEW PLAN REVISION - THE OLD PLAN STATUS GOES TO RETIRED AND A NEW REVISION IS UNAPPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4DITC TREATMENT PLANNING SYSTEM IYE VARIAN MEDICAL SYSTEMS, INC, ONCOLOGY SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1