BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN LINAC SYSTEM

    MDR report key: 17101286 · Received June 9, 2023

    Report

    Report Number
    3011233554-2023-00002
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    April 19, 2023
    Report Date
    July 18, 2023
    Manufacturer
    VIEWRAY, INCORPORATED
    Product Code
    IYE
    UDI-DI
    00868029000346
    PMA / PMN Number
    K212958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE INVESTIGATION WAS IDENTIFIED AS A PROCESS FAILURE OCCURRED RESULTING IN INCORRECT "INCLINOMETERHARDOFFSET" VALUES WITHIN THE MOTION CONTROLLER "MACHINEDATA" FILE BEING USED AFTER SYSTEM ACCEPTANCE. CORRECTIVE ACTION WAS INITIATED FOR THIS ISSUE AND NO FURTHER ACTION REQUIRED, THIS ISSUE WAS IDENTIFIED TO BE A ONE-OFF EVENT CAUSED BY THE INCORRECT DATA FILE BEING UPLOADED AND THE SYSTEM NOT BEING COMMISSIONED CORRECTLY.

    Additional Manufacturer Narrative · 0

    VIEWRAY IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON 20APRIL2023 A USER OF VIEWRAY'S MRIDIAN LINAC SYSTEM REPORTED AN ISSUE WITH THEIR SYSTEM'S GANTRY ANGLES MEASURING 1.7 DEGREES OUT OF SPECIFICATION. ON (B)(6) 2023 THE GANTRY OFFSETS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. DUE TO A MISTAKE BY A SITE OPERATOR ON (B)(6) 2023, AN EMERGENCY STOP WAS MISTAKENLY PRESSED CAUSING THE SYSTEM TO POWER DOWN. UPON POWERING THE SYSTEM BACK ON, THE VIEWRAY ONSITE ENGINEER IDENTIFIED THAT THE INCLINOMETER HAD FAILED RESULTING IN AN INCLINOMETER REPLACEMENT. ON (B)(6) 2023, THE SITE IRRADIATED ONE PATIENT AND AFTER TREATMENT, THE SITE DISCOVERED DURING QUALITY ASSURANCE CHECKS THAT THE GANTRY ANGLE WAS 1.7 DEGREES OFF. THE SITE REPORTED THERE WERE NO CONSEQUENCES FOR THE PATIENT SINCE THE TARGET VOLUME WAS CENTRAL AND SYMMETRICAL, AND THEREFORE NO RELEVANT DOSE DEVIATIONS OCCURRED. THIS WAS CONFIRMED BY RECALCULATION IN THE RADIATION PLANNING SYSTEM WITH DIFFERENT GANTRY ANGLES. ON (B)(6) 2023 VIEWRAY FIELD SERVICE ENGINEER CALIBRATED THE INCLINOMETER AND GANTRY OFFSETS BACK TO 0.0 DEGREES. THE CUSTOMER PERFORMED A STARSHOT ANALYSIS TO VERIFY AND CONFIRM THE INCLINOMETER AND GANTRY ANGLES WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237200 MRIDIAN LINAC SYSTEM MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM IYE VIEWRAY, INCORPORATED 20000-01 00868029000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other