BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 10148588 · Received June 12, 2020

    Report

    Report Number
    3007774465-2020-00001
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    May 12, 2020
    Report Date
    March 28, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K160093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PTV WAS MOVED UNINTENTIONALLY BY THE USER WHO ACCIDENTALLY CLICKED THE "SET TO SLICE INTERSECTION" IN THE PATIENT MODELING MENU. THE USER WAS WORKING FROM HOME ON A SMALL LAPTOP SCREEN, PROBABLY DUE TO THE COVID-19 SITUATION AS THIS WOULD NOT BE NORMAL USE OF THE DEVICE. THERE WAS NO MALFUNCTION OF THE DEVICE. THE SYSTEM LOG FILES HAVE BEEN REQUESTED.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR (B)(4) TARGET ROI MOVED BEFORE APPROVAL. NO SERIOUS ADVERSE EVENTS OCCURRED. USE ERROR. A RAYSTATION 5.0.2 USER REPORTS THAT THE RADIATION TARGET (PTV) AS SPECIFIED IN RAYSTATION WAS MOVED. A PATIENT WAS TREATED THE FIRST FRACTION WITH AN INCORRECT LOCATION OF THE PTV. NO IMPACT ON THE OUTCOME OF PATIENT TREATMENT IS EXPECTED. THE INCIDENT OCCURRED AROUND (B)(6) 2020. PLAN APPROVAL IN RAYSTATION WAS USED, EFFECTIVELY LOCKING ALL DELINEATED STRUCTURES SO THE PTV WAS MOVED BEFORE THE PLAN WAS APPROVED FOR DELIVERY. USER REVIEW AT APPROVAL FAILED TO DETECT THE INCORRECT PTV.T.

    Description of Event or Problem · 1

    A RAYSTATION 5.0.2 USER REPORTS THAT THE RADIATION TARGET (PTV) AS SPECIFIED IN RAYSTATION WAS MOVED. A PATIENT WAS TREATED THE FIRST FRACTION WITH AN INCORRECT LOCATION OF THE PTV. NO IMPACT ON THE OUTCOME OF PATIENT TREATMENT IS EXPECTED. THE INCIDENT OCCURRED AROUND (B)(6) 2020. PLAN APPROVAL IN RAYSTATION WAS USED, EFFECTIVELY LOCKING ALL DELINEATED STRUCTURES SO WE ARE CONFIDENT THAT THE PTV WAS MOVED BEFORE THE PLAN WAS APPROVED FOR DELIVERY. USER REVIEW AT APPROVAL FAILED TO DETECT THE INCORRECT PTV. BASED ON DISCUSSIONS WITH THE USER, IT IS LIKELY THAT THE PTV WAS MOVED UNINTENTIONALLY BY THE USER BY ACCIDENTALLY CLICKING THE "SET TO SLICE INTERSECTION" IN THE PATIENT MODELING MENU. THE USER WAS WORKING FROM HOME ON A SMALL LAPTOP SCREEN, PROBABLY DUE TO THE COVID-19 SITUATION AS THIS WOULD NOT BE NORMAL USE OF THE DEVICE. PRELIMINARY ASSESSMENT IS THAT THERE WAS NO MALFUNCTION OF THE DEVICE. THE SYSTEM LOG FILES HAVE BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610867 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other