BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRIDIAN A3I SYSTEM

    MDR report key: 24818897 · Received April 8, 2026

    Report

    Report Number
    3007546534-2026-00001
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 8, 2026
    Manufacturer
    VIEWRAY SYSTEMS INC.
    Product Code
    IYE
    PMA / PMN Number
    K212958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VIEWRAY SYSTEMS INVESTIGATED THIS ISSUE BY EXAMINING THE DEVICE AND LOGFILES WHICH CONFIRMED THE SYSTEM OPERATED ACCORDING TO SPECIFICATION AND FUNCTIONED AS DESIGNED. THE SYSTEM DETECTED THE OBSTRUCTION AND HALTED MOVEMENT WHEN THE INCIDENT OCCURRED. THE SYSTEM DID NOT MALFUNCTION.

    Description of Event or Problem · 0

    AFTER COMPLETING A PATIENT TREATMENT, THE USER MOVED THE TABLE TO HOME POSITION WHICH UNEXPECTEDLY ENTANGLED THE CABLES OF A THIRD-PARTY MONITORING DEVICE. AS THE USER ATTEMPTED TO FREE THE CABLE A SECOND OPERATOR SIMULTANEOUSLY INITIATED TABLE MOTION WHICH TRAPPED THE INITIAL USER'S FINGER BETWEEN THE TABLE AND BORE/INLET SHROUD. THE SYSTEM DETECTED RESISTANCE, ISSUED A FAULT, AND HALTED MOTION. THE USER CLEARED THE FAULT AND MOVED THE TABLE UPWARD TO RELEASE THE FINGER RESULTING IN SERIOUS INJURY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884762 MRIDIAN A3I SYSTEM MRIDIAN A3I SYSTEM IYE VIEWRAY SYSTEMS INC. 20000-01 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O