BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN AND MRIDIAN LINAC

    MDR report key: 10719261 · Received October 22, 2020

    Report

    Report Number
    3011233554-2020-00001
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 22, 2020
    Manufacturer
    VIEWRAY, INC.
    Product Code
    IYE
    PMA / PMN Number
    K170751
    Removal / Correction Number
    10-20-2020-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING INTERNAL TESTING VIEW RAY IDENTIFIED TWO SITUATIONS WHERE COMPONENTS OF THE RECEIVE COIL CAN REACH ELEVATED TEMPERATURES, WHICH HAS THE POTENTIAL TO CAUSE A BURN INJURY TO THE PATIENT OR USER. VIEW RAY DETERMINED THAT THE RECEIVE COIL FEED BOARD BOX, EXCEEDED TEMPERATURE SPECIFICATIONS DURING USE OF SEQUENCES REQUIRING INCREASED RF POWER (E.G. 8FPS CINE IMAGING) WHEN IT IS IN PROXIMITY (<15CM) TO THE BORE WALL IN MERIDIAN LINAC SYSTEM (P/N 20000). VIEW RAY DETERMINED THAT THE OPTIONAL TWO FRAMES PER SECOND IN THREE PLANES CINE TRACKING FEATURE IN USE IN THE MERIDIAN SYSTEM (P/N 10000) MAY ALSO CAUSE UNEXPECTED HEATING OF THE RECEIVE COIL FEED BOARD BOX. THIS ISSUE HAS ONLY BEEN REPORTED THROUGH INTERNAL TESTING. TO DATE, THERE HAVE BEEN NO CUSTOMER REPORTS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185382 MRIDIAN AND MRIDIAN LINAC RADIATION THERAPY IYE VIEWRAY, INC. 10000, 20000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1