BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16491897 · Received March 6, 2023

    Report

    Report Number
    3007774465-2023-00015
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    October 13, 2020
    Report Date
    March 3, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K200569
    Removal / Correction Number
    RES 86832
    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. IF THE INCORRECT ANGLES ARE USED FOR INITIAL SETUP ONLY AND THE INCORRECT SETUP IS THEN DETECTED USING IMAGING, THERE COULD BE UNNECESSARY IMAGING DOSE IF REPEAT IMAGES ARE REQUIRED AFTER CORRECTION. IF THE INCORRECT PITCH/ROLL VALUES ARE NOT DETECTED AND USED FOR TREATMENT, THIS COULD LEAD TO LOCAL OVER-DOSE IN A RISK ORGAN OR LOCAL UNDER-DOSAGE TO THE TARGET. SEVERITY WOULD DEPEND ON THE ANGLES USED. SMALL ERROR => SMALL IMPACT, EXCEPT FOR TREATENT WITH SMALL MARGINS, E.G. STEREOTACTIC TREATMENTS, WHERE EVEN A SMALL ANGLE DEVIATION COULD HAVE AN IMPACT.

    Description of Event or Problem · 0

    NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. THERE ARE THREE BUGS RELATED TO PITCH AND ROLL PARAMETERS IN REPORTS FOR 6D COUCH: A) BUG 283056: [NON-IEC] DISPLAYED FOR COUCH PITCH AND COUCH ROLL IN HEADER AND BEAM DATA SECTION IN REPORT COUCH PITCH AND ROLL PARAMETERS ARE ALWAYS DEFINED ACCORDING TO IEC61217 STANDARD IN RAYSTATION. HOWEVER, IF THE MACHINE IS DEFINED IN RAYPHYSICS WITH NON-IEC FOR COUCH ANGLE, THE REPORT WILL SHOW UNITS FOR PITCH/ROLL AS "NON-IEC". B) BUG 281806: COUCH ROLL PARAMETER IS NOT SET CORRECTLY FOR SETUP BEAMS IN PLAN REPORTS C) BUG 282677: NO CONVERTER SHOULD BE USED FOR COUCH PITCH/ROLL PARAMETERS IN REPORT SETUP BEAMS TABLE FOR SETUP BEAMS, COUCH ROLL WILL ALWAYS BE INCORRECTLY ASSIGNED THE VALUE OF COUCH ANGLE IN THE PLAN REPORT. IF NON-IEC DEFINITION IS USED FOR COUCH ANGLE, COUCH PITCH WILL ALSO BE INCORRECT.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00015 68727 RS TREATMENT PLAN REPORT RSL. NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. THERE ARE THREE BUGS RELATED TO PITCH AND ROLL PARAMETERS IN REPORTS FOR 6D COUCH: A) BUG 283056: [NON-IEC] DISPLAYED FOR COUCH PITCH AND COUCH ROLL IN HEADER AND BEAM DATA SECTION IN REPORT COUCH PITCH AND ROLL PARAMETERS ARE ALWAYS DEFINED ACCORDING TO IEC61217 STANDARD IN RAYSTATION. HOWEVER, IF THE MACHINE IS DEFINED IN RAYPHYSICS WITH NON-IEC FOR COUCH ANGLE, THE REPORT WILL SHOW UNITS FOR PITCH/ROLL AS "NON-IEC". B) BUG 281806: COUCH ROLL PARAMETER IS NOT SET CORRECTLY FOR SETUP BEAMS IN PLAN REPORTS C) BUG 282677: NO CONVERTER SHOULD BE USED FOR COUCH PITCH/ROLL PARAMETERS IN REPORT SETUP BEAMS TABLE. FOR SETUP BEAMS, COUCH ROLL WILL ALWAYS BE INCORRECTLY ASSIGNED THE VALUE OF COUCH ANGLE IN THE PLAN REPORT. IF NON-IEC DEFINITION IS USED FOR COUCH ANGLE, COUCH PITCH WILL ALSO BE INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707084 RAYSTATION RADIATION THERAPY TREATNEBT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4-10A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown