BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN LINAC

    MDR report key: 13191204 · Received January 7, 2022

    Report

    Report Number
    3011233554-2022-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    January 12, 2020
    Report Date
    January 7, 2022
    Manufacturer
    VIEWRAY, INC.
    Product Code
    IYE
    UDI-DI
    10868029000305
    PMA / PMN Number
    K170751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS DUE TO A RETROSPECTIVE REVIEW OF A HEALTH HAZARD EVALUATION (HHE) AND THE REMOTE POTENTIAL FOR SERIOUS INJURY TO SERVICE PERSONNEL. THE 806.20 RECALL FOR THIS ISSUE HAS BEEN COMPLETED AND FIELD CHANGE NOTICE FCN-0001 TRACK ROLLER LUBRICATION INSTRUCTIONS INITIAL SERVICE, FCN-0002 GANTRY TRACK-ROLLER HEALTH AND BOGEY ALIGNMENT INSPECTION AND FCN-0003 GANTRY TRACK-ROLLER HEALTH AND BOGEY ALIGNMENT INSPECTION. THE INSPECTION OF THE GANTRY TRACK ROLLER HEALTH IS NOW INCLUDED WITH PREVENTATIVE MAINTENANCE. VIEWRAY HAS NOT RECEIVED ANY REPORTS OF SERIOUS INJURY TO THE AFFECTED GROUPS INCLUDING PATIENTS, USERS AND SERVICE PERSONNEL.

    Description of Event or Problem · 0

    VIEWRAY'S DISTRIBUTOR REPORTED AN OCCURRENCE WHERE THE GANTRY CAME OFF THE VAULT PLATE AND PRODUCED AN ERROR MESSAGE. THE SYSTEM DISPLAYED ERROR MESSAGE RT08011 WITH A DIALOG MESSAGE STATING "GANTRY MOTOR OPERATING CURRENT LIMITS HAVE BEEN EXCEEDED. CALL SERVICE." THIS ERROR CODE IS A HARDWARE ERROR. THE ERROR CODE IS CAUSED BY HARDWARE ISSUE. THE SYSTEM SHOWS THE ERROR MESSAGE AND ABORTS TREATMENT IF IN SESSION. THE USER SHOULD CALL VIEWRAY SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991903 MRIDIAN LINAC RADIATION THERAPY IYE VIEWRAY, INC. 20000 10868029000305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown