BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORT300 TABLE

    MDR report key: 18088480 · Received November 7, 2023

    Report

    Report Number
    3010326005-2023-00012
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 9, 2023
    Report Date
    November 7, 2023
    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

    THE IMRIS CUSTOMER SERVICE ENGINEER INVESTIGATED THE ISSUE ON-SITE AND OBSERVED A SMALL HYDRAULIC FLUID LEAK FROM A PRESSURIZED INPUT HOSE ASSOCIATED WITH THE BACK LIFT CYLINDER. THE CSE MEASURED THE HYDRAULIC FLUID LEVEL IN THE OPERATING ROOM TABLE AND CONFIRMED IT WAS WITHIN SPECIFICATION. THE TABLE WAS FUNCTIONALLY TESTED AND NO FUNCTIONAL ISSUES WERE PRESENT OR PREVIOUSLY REPORTED BY THE CUSTOMER. REPLACEMENT OF THE HYDRAULIC HOSE IS IN PROCESS; A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE IMRIS SERVICE ENGINEER REPLACED FLOW CONTROL VALVES AND ADDITIONAL HYDRAULIC HOSES AND FITTINGS IN THE HYDRAULIC SYSTEM ADJACENT TO THE FLOW CONTROL VALVES TO ADDRESS THE REPORTED FLUID LEAK. HYDRAULIC FLUID LEVELS AND SYSTEM PRESSURE WERE MEASURED DURING THE SERVICE VISITS AND CONFIRMED TO BE WITHIN SPECIFICATION. NO TABLE FUNCTIONAL IMPACT WAS REPORTED BY THE CUSTOMER OR OBSERVED BY THE SERVICE ENGINEER THROUGHOUT MULTIPLE SITE VISITS, ON-SITE TESTING, AND FOLLOWUP PREVENTIVE MAINTENANCE VISITS. THIS REPORT ALSO ENCOMPASSES UDI RELATED DATA QUALITY UPDATES TO MATCH BRAND NAME AND UDI WITH GUDID DATA.

    Description of Event or Problem · 0

    A BIOMEDICAL TECHNICIAN AT THE CUSTOMER SITE REPORTED OBSERVING HYDRAULIC FLUID AT THE BASE OF THE ORT300 OPERATING ROOM TABLE. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT AT THE TIME OF THE OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536982 ORT300 TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT300 00857534006356

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other