BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 2989709 · Received February 14, 2013

    Report

    Report Number
    2916710-2013-00003
    Event Type
    Other
    Date Received
    February 14, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. OTHER: THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WAS SET UP FOR TREATMENT WITH THE COUCH AT 90 DEGREE WITH A GANTRY AUTO-GOTO MOVEMENT THRU THE DEDICATED KEYBOARD AND THE GANTRY TOUCHED AND SLIGHTLY PRESSED THE PATIENT'S ABDOMEN. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64879 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H29

    Patients

    Seq Age Sex Outcome Treatment
    1