BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT300 OPERATING ROOM TABLE

    MDR report key: 15316924 · Received August 29, 2022

    Report

    Report Number
    3010326005-2022-00014
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    July 30, 2022
    Report Date
    July 30, 2022
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    UDI-DI
    00857534006356
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED SOURCE OF THE FLUID LEAK IS A VALVE COMPONENT WITHIN THE HYDRAULIC MANIFOLD. NO HYDRAULIC PRESSURE LOSS OR IMPACT ON TABLE FUNCTION HAS BEEN OBSERVED. A FOLLOWUP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AN IMRIS CUSTOMER SERVICE ENGINEER MADE MULTIPLE SITE VISITS TO ADDRESS THE PREVENTIVE MAINTENANCE FINDING OF A SMALL HYDRAULIC FLUID LEAK FROM THE OPERATING ROOM TABLE. THE SOURCE OF THE LEAK WAS NOT DEFINITIVELY DETERMINED, AT A FOLLOWUP VISIT NO FLUID OUTSIDE THE HYDRAULIC SYSTEM WAS OBSERVED. MULTIPLE SUSPECTED HYDRAULIC SYSTEM COMPONENTS WERE REPLACED AS A PREVENTIVE MEASURE, INCLUDING A FLOW CONTROL VALVE, A HOSE, AND MULTIPLE FITTINGS AND UNIONS. HYDRAULIC SYSTEM PRESSURE AND FLUID LEVELS WERE MEASURED TO BE WITHIN SPECIFICATION, AND WEIGHTED DRIFT TESTING WAS PERFORMED WITH PASSING RESULTS. NO IMPACT TO TABLE FUNCTION WAS REPORTED OR OBSERVED.

    Description of Event or Problem · 0

    DURING ROUTINE PREVENTIVE MAINTENANCE, AN IMRIS CUSTOMER SERVICE ENGINEER OBSERVED SEVERAL SMALL DROPS OF HYDRAULIC FLUID ON OUTSIDE OF THE HYDRAULIC LINES OF THE ORT300 OPERATING ROOM TABLE. NO ISSUES WERE REPORTED OR OBSERVED WITH RESPECT TO HYDRAULICS CONTROLLED TABLE FUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243173 IMRIS ORT300 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT300 00857534006356

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown