BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 1876577 · Received October 13, 2010

    Report

    Report Number
    2916710-2010-00114
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K050479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION IN THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN 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'S REPORTED PATIENT "(B)(6)" DISPLAYED IN OBI WHEN PATIENT "(B)(6)" IS MODED UP ON 4DITC. THERAPIST LOADED PATIENT (B)(6), ON 4DTC. PATIENT (B)(6) SHOWED ON OBI (THIS PATIENT WAS TREATED AND IMAGED 2 PATIENTS PRIOR. THOSE 2 PATIENTS WERE ALSO IMAGED). THERAPISTS CLOSED PATIENT ON 4DTC, CLOSED TREAT AND OBI APPS, AFTER LAUNCHING APPS AND LOADING PATIENT, CORRECT PATIENT AND IMAGES APPEARED IN TREAT AND OBI APPS. THERAPISTS CHECKED PATIENTS IN OLR, AND THE CORRECT IMAGES WERE ASSOCIATED TO THE CORRECT PATIENTS. THERE WAS NO REPORT OF INJURY TO THE PATIENT AND NO PATIENT DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE LINEAR ACCELERATOR SOFTWARE IYE VARIAN MEDICAL SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1