BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16501829 · Received March 8, 2023

    Report

    Report Number
    3007774465-2023-00026
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    October 22, 2018
    Report Date
    March 12, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K190387
    Removal / Correction Number
    RES 81693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON AN INCORRECT BACKGROUND DOSE, THIS COULD LEAD TO THE APPROVAL OF AN INAPPROPRIATE DOSE PLAN. THIS COULD LEAD TO LOCAL OVER-DOSE IN A RISK ORGAN FROM ALLOWING TOO HIGH OF A DOSE IN THE TREATMENT PLAN.

    Description of Event or Problem · 0

    NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. WHEN USING ESTIMATE FRACTION DOSE IN THE DOSE TRACKING MODULE, IT IS POSSIBLE TO ENTER ISOCENTER SHIFTS AS X, Y, Z. THE COORDINATE SYSTEM IS NOT SPECIFIED, WHICH MEANS IT IS INTENDED TO BE THE IEC PATIENT COORDINATE SYSTEM. HOWEVER, A COORDINATE TRANSFORMATION IS MISSING IN THE CODE. RAYSTATION USES THE DICOM PATIENT COORDINATE SYSTEM INTERNALLY AND THIS IS HOW THE COORDINATES ARE INTERPRETED IN THIS DIALOG. THE ERROR ONLY APPLIES TO DOSE TRACKING. THE SAME FUNCTION IS AVAILABLE IN PLAN EVALUATION, WHERE X,Y,Z IS CORRECTLY INTERPRETED AS IEC PATIENT COORDINATES. IF NOT DETECTED, THE ERRONEOUS SHIFT WOULD AFFECT THE ESTIMATED FRACTION DOSE. THIS DOSE COULD BE USED AS BACKGROUND DOSE, SO COULD POTENTIALLY AFFECT A NEW, ADAPTED TREATMENT PLAN.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00026 37483 RS ISO SHIFT COORD IN DOSE TRACKING. NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. WHEN USING ESTIMATE FRACTION DOSE IN THE DOSE TRACKING MODULE, IT IS POSSIBLE TO ENTER ISOCENTER SHIFTS AS X, Y, Z. THE COORDINATE SYSTEM IS NOT SPECIFIED, WHICH MEANS IT IS INTENDED TO BE THE IEC PATIENT COORDINATE SYSTEM. HOWEVER, A COORDINATE TRANSFORMATION IS MISSING IN THE CODE. RAYSTATION USES THE DICOM PATIENT COORDINATE SYSTEM INTERNALLY AND THIS IS HOW THE COORDINATES ARE INTERPRETED IN THIS DIALOG. THE ERROR ONLY APPLIES TO DOSE TRACKING. THE SAME FUNCTION IS AVAILABLE IN PLAN EVALUATION, WHERE X,Y,Z IS CORRECTLY INTERPRETED AS IEC PATIENT COORDINATES. IF NOT DETECTED, THE ERRONEOUS SHIFT WOULD AFFECT THE ESTIMATED FRACTION DOSE. THIS DOSE COULD BE USED AS BACKGROUND DOSE, SO COULD POTENTIALLY AFFECT A NEW, ADAPTED TREATMENT PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121465 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 3.5-8A SP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown