BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYCARE

    MDR report key: 16492263 · Received March 6, 2023

    Report

    Report Number
    3010034862-2023-00012
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 10, 2021
    Report Date
    March 7, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    UDI-DI
    07350002010341
    PMA / PMN Number
    K200487
    Removal / Correction Number
    RES 87471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR IN RAYCARE 3A HAS BEEN IDENTIFIED. WHEN UPGRADING FROM RAYCARE 2 TO RAYCARE 3A AN ERROR IS INTRODUCED. THE ERROR HOWEVER DOES NOT MANIFEST UNTIL AN UPGRADE TO 3B OR LATER IS DONE. RAYCARE 3A CAN BE SAFELY USED. IF, THE MISSING MESSAGE BODY TEXT CONTAINS INFORMATION THAT IS INTENDED TO INFLUENCE TREATMENT PLANNING OR INSTRUCTIONS ON PATIENT CARE, THE TREATMENT MAY NOT BE PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    NO SERIOUS EVENT OCCURRED. NO PATIENTS WERE AFFECTED. A CUSTOMER NOTICED A MALFUNCTION AFTER UPGRADE OF THE SYSTEM. THIS ISSUE WAS FOUND IN THE RAYCARE UPGRADE. MESSAGE BODY FROM PATIENT RELATED MESSAGES CREATED IN RAYCARE 3B, RAYCARE 4A WILL BE LOST WHEN UPGRADING FROM RAYCARE 2 TO RAYCARE 3B OR LATER.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MDR 3010034862-2023-00012 75198 RC MESSAGE CONTENTS LOST. NO SERIOUS EVENT OCCURRED. NO PATIENTS WERE AFFECTED. A CUSTOMER NOTICED A MALFUNCTION AFTER UPGRADE OF THE SYSTEM. THIS ISSUE WAS FOUND IN THE RAYCARE UPGRADE. MESSAGE BODY FROM PATIENT RELATED MESSAGES CREATED IN RAYCARE 3B, RAYCARE 4A WILL BE LOST WHEN UPGRADING FROM RAYCARE 2 TO RAYCARE 3B OR LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705950 RAYCARE RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYCARE 3B, RAYCARE 4A 07350002010341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown