BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 3040281 · Received April 3, 2013

    Report

    Report Number
    2916710-2013-00007
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. 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. (B)(4).

    Description of Event or Problem · 1

    PHYSICIST DETERMINED BEAM SYMMETRY IN THE RADIAL PLANE OF 6X IS 4.3%, THE CLINAC DID NOT TRIP A SYMMETRY INTERLOCK AND CONTINUED TO DELIVER BEAM. VERIFIED THAT THE RADIAL PLANE OF 6X BEAM IS AT 4.3% AND THE CLINAC DOES NOT INTERLOCK. THERAPISTS PERFORMED A MORNING CHECKOUT WITH A DEVICE USED ON THE MORNING OF (B)(6) 2013 AND THE CLINAC PASSED SYMMETRY AND OUTPUT CHECKS. TREATMENTS WERE DELIVERED FOR THE ENTIRE DAY AND THIS ISSUE WAS DISCOVERED IN THE EVENING AFTER TREATMENTS BY PHYSICS. NO WORK WAS DONE ON THE CLINAC BY IN HOUSE ENGINEERING OR VARIAN DURING THIS TIME PERIOD. IT IS UNK WHAT TIME OF DAY THIS OCCURRED AND HOW MANY PTS MAY HAVE BEEN AFFECTED. TREATMENTS WERE STOPPED WHEN THE ISSUE WAS DISCOVERED ON THE EVENING OF (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135915 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H29

    Patients

    Seq Age Sex Outcome Treatment
    1