BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OR TABLE V2 (ORT100)

    MDR report key: 14805692 · Received June 24, 2022

    Report

    Report Number
    3010326005-2022-00010
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 25, 2022
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    UDI-DI
    00857534006332
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HYDRAULIC FLUID LEAK WAS TRACED TO THE O-RING GASKET BETWEEN THE HYDRAULIC FLUID RESERVOIR AND THE HYDRAULIC PUMP. THE GASKET HAD DEGRADED OVER TIME AND REQUIRED REPLACEMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, DURING PREVENTIVE MAINTENANCE AN IMRIS CUSTOMER SERVICE ENINGINEER OBSERVED A SMALL LEAK OF HYDRAULIC FLUID IN THE WALL MOUNTED CONTROL PANEL OF THE T2X OPERATING ROOM TABLE. THERE WAS NO PATIENT INVOLVEMENT AND THE TABLE PASSED FUNCTIONAL TESTING DURING THE PREVENTIVE MAINTENANCE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055916 IMRIS T2X OR TABLE V2 (ORT100) OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT100 00857534006332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown