BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16452877 · Received February 28, 2023

    Report

    Report Number
    3007774465-2023-00006
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    December 17, 2021
    Report Date
    March 14, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K200569
    Removal / Correction Number
    RES 89631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. IN THE STRUCTURE DEFINITION MODULE, REGISTERED IMAGE SETS CAN BE VIEWED IN A SIDE-BY-SIDE MODE. A 4D IMAGE SET CAN BE VIEWED AS A "CINE LOOP", RUNNING THROUGH THE 3D IMAGE SETS AS A SEQUENCE. IF A NEW PRIMARY IMAGE SET IS SELECTED WHILE THE "CINE LOOP" IS RUNNING, THE PRIMARY IMAGE SET WILL BE DISPLAYED AS BOTH PRIMARY AND SECONDARY IMAGE SET IN ALL SIDE-BY-SIDE VIEWS. THIS WILL ALSO BE TRUE FOR ANY NEW PATIENT CASE OPENED WHILE THE "CINE LOOP" IS RUNNING. THE ERROR WILL PERSIST UNTIL RAYSTATION IS RESTARTED. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON INCOMPLETE INFORMATION DUE TO THE BUG, THIS COULD LEAD TO HARM THROUGH INAPPROPRIATE TARGET DELINEATION DURING TREATMENT PLANNING OR CONTINUED TREATMENT WITH A PLAN THAT WOULD OTHERWISE HAVE BEEN ADJUSTED. THIS COULD LEAD TO LOCAL OVER-DOSE IN A RISK ORGAN OR LOCAL UNDER-DOSAGE TO THE TARGET.

    Description of Event or Problem · 0

    A CUSTOMER NOTICED AN INCORRECT DISPLAY OF PATIENT IMAGES IN RAYSTATION DURING TREATMENT PLANNING. THIS HAD NO EFFECT ON PATIENT TREATMENT, BUT THE MALFUNCTION WAS REPORTED TO THE MANUFACTURER AS A SAFETY COMPLAINT. THIS NOTICE CONCERNS AN ISSUE FOUND WITH THE DISPLAY OF SECONDARY IMAGE SETS IN A SIDE-BY-SIDE VIEW IN RAYSTATION/RAYPLAN 6, 7, 8A, 8B, 9A, 9B INCLUDING SOME SERVICE PACKS. THE PRIMARY IMAGE SET MAY BE DISPLAYED INSTEAD OF THE SECONDARY IMAGE SET.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00006 90375 RS SECONDARY IMAGE VIEW. A CUSTOMER NOTICED AN INCORRECT DISPLAY OF PATIENT IMAGES IN RAYSTATION DURING TREATMENT PLANNING. THIS HAD NO EFFECT ON PATIENT TREATMENT, BUT THE MALFUNCTION WAS REPORTED TO THE MANUFACTURER AS A SAFETY COMPLAINT. IN THE STRUCTURE DEFINITION MODULE, REGISTERED IMAGE SETS CAN BE VIEWED IN A SIDE-BY-SIDE LAYOUT. A 4D IMAGE SET CAN BE SHOWN AS A "CINE LOOP", RUNNING THROUGH THE 3D IMAGE SETS AS A SEQUENCE. THE CINE LOOP IS STARTED BY CLICKING THE PLAY BUTTON IN THE LOWER LEFT CORNER OF THE VIEW DISPLAYING THE 4D IMAGE SET. IF A CINE LOOP IS STARTED IN THE VIEW OF THE PRIMARY IMAGE SET, THE SAME CINE LOOP WILL BE DISPLAYED IN ALL SIDEBY- SIDE VIEWS, I.E., ALSO IN THE VIEW OF THE SECONDARY IMAGE SET, REGARDLESS OF WHICH IMAGE SET IS SELECTED AS SECONDARY. IF A NEW PRIMARY IMAGE SET IS SELECTED WHILE THE CINE LOOP IS RUNNING, THE PRIMARY IMAGE SET WILL BE DISPLAYED AS BOTH PRIMARY AND SECONDARY IMAGE SET IN ALL SIDE-BY-SIDE VIEWS. THIS WILL ALSO BE TRUE FOR ANY NEW PATIENT OR CASE OPENED WHILE THE CINE LOOP IS RUNNING. THE ERROR WILL PERSIST UNTIL THE AFFECTED INSTANCE OF RAYSTATION/RAYPLAN IS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560883 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION/RAYPLAN 6, 7. 8A, 8B, 9A, 9B INCLUDING SOME SERVICE PACKS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown