BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4DITC

    MDR report key: 1991348 · Received January 26, 2011

    Report

    Report Number
    2916710-2010-00166
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 29, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. 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

    A DOSIMETRIST CALLED REGARDING A PLAN THAT DID NOT SAVE PROPERLY (CUSTOMER'S PERCEPTION) AND ALLOWED THE RADIATION THERAPISTS (RTT'S) TO MODE UP AND TREAT THE ORIGINAL PLAN (NOW RETIRED) INSTEAD OF THE NEWLY REVISED PLAN (TREATMENT APPROVED). THE PATIENT WAS TREATED CORRECTLY, AS IT WAS THE SAME PLAN WITH ADDED FRACTIONS ONLY, HOWEVER, THE CUSTOMER IS CONCERNED THAT IN A DIFFERENT SCENARIO, THE PLAN MAY HAVE BEEN COMPLETELY CHANGED. ONE SHOULD NOT BE ABLE TO MODE UP A RETIRED PLAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1