BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN SYSTEMS

    MDR report key: 9363580 · Received November 22, 2019

    Report

    Report Number
    3011233554-2019-00006
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 10, 2019
    Report Date
    November 22, 2019
    Manufacturer
    VIEWRAY, INC.
    Product Code
    IYE
    PMA / PMN Number
    K170751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE MERIDIAN SYSTEM PROVIDES USERS THE OPTIONAL ABILITY TO IMPORT DOSE PREVIOUSLY DELIVERED TO A PATIENT IN ORDER TO ADD THIS DOSE TO A NEW TREATMENT PLAN. WHEN THIS INFREQUENTLY-USED OPTION IS UTILIZED, THE IMPORTED DOSE MAY BE MISALIGNED WITH THE CURRENTLY DISPLAYED PATIENT ANATOMY AND STRUCTURES. IN THE TREATMENT DELIVERY WORKFLOW, THE TPDS SOFTWARE PRESENTS EVIDENCE OF THIS MISALIGNMENT TO THE USER IN THE PREDICTED DVH. HOWEVER, DEPENDING ON THE MAGNITUDE OF THE MISALIGNMENT THE IMPACT MAY NOT BE OBVIOUS TO THE USER. AS A RESULT, DURING PLAN RE-OPTIMIZATION THE PREVIOUSLY DELIVERED DOSE WOULD BE INCORRECTLY ACCOUNTED FOR BY THE SOFTWARE AND MAY RESULT IN UNEXPECTEDLY HIGHER OR LOWER DOSE THAN THE INTENDED DOSE CALCULATED FOR THE SUBSEQUENT TREATMENT PLAN. WHEN THIS ISSUE OCCURS IN THE TREATMENT PLANNING WORKFLOW, REGISTRATION FAILS TO ALIGN THE DOSE WITH THE IMAGE, AND THE USER IS UNABLE TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154915 MRIDIAN SYSTEMS MRIDIAN SYSTEMS IYE VIEWRAY, INC. 20000, 10000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other