BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT300 OPERATING ROOM TABLE

    MDR report key: 15080468 · Received July 21, 2022

    Report

    Report Number
    3010326005-2022-00012
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 21, 2022
    Report Date
    June 21, 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN IMRIS CUSTOMER SERVICE ENGINEER ADDRESSED THE ISSUE ON-SITE. UPON INSPECTION, THE CSE CONFIRMED PRESENCE OF A HYDRAULIC FLUID LEAK AND TRACED IT TO THE CONNECTION BETWEEN A PTFE HYDRAULIC LINE AND THE TRENDELENBURG CYLINDER. THE FITING SECURING THE CONNECTION WAS ADJUSTED AND TIGHTENED. THE CSE MEASURED THE HYDRAULIC FLUID LEVEL IN THE OPERATING ROOM TABLE AND CONFIRMED IT WAS WITHIN SPECIFICATION. NO COMPONENTS REQUIRED REPLACEMENT AND NO ADDITIONAL FLUID WAS ADDED TO THE TABLE. THE TABLE WAS TESTED TO CONFIRM FUNCTION AFTER THE ISSUE WAS ADDRESSED; NO TABLE FUNCTIONAL ISSUES WERE OBSERVED BY THE CSE OR REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT DURING A MORNING QA, DROPS OF HYDRAULIC FLUID WERE OBSERVED AT THE BASE OF THE ORT300 OPERATING ROOM TABLE. NO ISSUES WERE REPORTED WITH RESPECT TO HYDRAULICS CONTROLLED TABLE FUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT WHEN THE APPARENT LEAK WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89569 IMRIS ORT300 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT300 00857534006356

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown