BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORT300 TABLE

    MDR report key: 23597673 · Received November 19, 2025

    Report

    Report Number
    3010326005-2025-00005
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 22, 2025
    Report Date
    November 19, 2025
    Manufacturer
    IMRIS IMAGING, INC.
    Product Code
    FQO
    UDI-DI
    00857534006356
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VALVE FITTINGS WERE TIGHTENED TO PREVENT FURTHER LEAKING AND IMRIS CUSTOMER SERVICE ENGINEER ORDERED THE NECESSARY PARTS TO REPLACE ALL LEAKING VALVES ALONG WITH A NEW RESERVOIR TANK. THE END USER WAS NOTIFIED OF THE FINDING AND THE ORT300 REMAINS FUNCTIONAL.

    Description of Event or Problem · 0

    THE CUSTOMER NOTIFIED IMRIS CUSTOMER SERVICE ENGINEER VIA EMAIL, STATING THEY HAD OBSERVED OIL COMING FROM THE ORT300 OPERATING ROOM TABLE. THE IMRIS CSE INSPECTED THE TABLE AND IDENTIFIED SMALL AMOUNTS OF HYDRAULIC FLUID LEAKING FROM THE UNPRESSURIZED FLUID RESERVOIR AND FROM MULTIPLE VALVES WITHIN THE PRESSURIZED HYDRAULIC CONTROL SYSTEM. NO TABLE FUNCTIONAL ISSUES WERE IDENTIFIED OR REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310223 ORT300 TABLE Table, operating-room, ac-powered FQO IMRIS IMAGING, INC. 114093-000 00857534006356

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other