BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 2000513 · Received February 1, 2011

    Report

    Report Number
    2916710-2011-00004
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 10, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO CRITICAL STRUCTURES WERE IN THE EXTRA TREATMENT FIELD. THE THERAPIST COMPENSATED BY GIVING ONE LESS BOOST FIELD. THOUGH MISADMINISTRATION DID OCCUR, THE ERROR WAS 4% AND UNLIKELY TO CAUSE SERIOUS INJURY. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. 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 FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE ISSUE AS REPORTED INDICATES THAT A NON RECORDED SESSION MAY HAVE OCCURRED, RESULTING IN A PT RECEIVING A HIGHER TOTAL DOSE THAN WHAT WAS PLANNED. IT WAS REPORTED THAT THE PT RECEIVED 5200 CGY AND THE PLAN WAS FOR 5000 CGY. THE SITE HAS INDICATED THEY WILL DELIVER ONE LESS BOOST FRACTION FOR COMPENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE DELIVERY SYSTEMS IYE VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1