BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORT300 TABLE

    MDR report key: 17375352 · Received July 21, 2023

    Report

    Report Number
    3010326005-2023-00008
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 24, 2023
    Report Date
    July 21, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMRIS CUSTOMER SERVICE ENGINEER ADDRESSED THE ISSUE ON-SITE. A FITTING SECURING A PRESSURIZED HYDRAULIC LINE CONNECTION WAS IDENTIFIED AS THE SOURCE OF THE LEAK AND WAS ADJUSTED AND TIGHTENED. 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. THE CSE INSPECTED THE TABLE ON A FOLLOW-UP SITE VISIT AND CONFIRMED THE ABSENCE OF ANY FLUID LEAKS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE IMRIS SERVICE ENGINEER REPLACED FITTINGS AND HOSES WITHIN THE HYDRAULIC SYSTEM THAT CONTROLS TRENDELENBURG POSITION ARTICULATION. HYDRAULIC FLUID LEVELS AND SYSTEM PRESSURE WERE MEASURED DURING MULTIPLE SERVICE VISITS AND CONFIRMED TO BE WITHIN SPECIFICATION. NO TABLE FUNCTIONAL IMPACT WAS REPORTED BY THE CUSTOMER OR OBSERVED BY THE SERVICE ENGINEER DURING THE SITE VISITS. THE SERVICE ENGINEER PERFORMED DRIFT TESTING TWICE DURING THE REPAIR PERIOD, WHICH PASSED. FOLLOWUP PREVENTIVE MAINTENANCE HAS CONFIRMED ABSENCE OF FURTHER FLUID LEAK. THIS REPORT ALSO ENCOMPASSES UDI RELATED DATA QUALITY UPDATES TO MATCH BRAND NAME AND UDI WITH GUDID DATA.

    Description of Event or Problem · 0

    DURING ROUTINE PREVENTIVE MAINTENANCE, AN IMRIS CUSTOMER SERVICE ENGINEER OBSERVED DROPS OF HYDRAULIC FLUID OUTSIDE OF THE HYDRAULIC LINES OF THE ORT300 OPERATING ROOM TABLE. THE SOURCE OF THE LEAK WAS TRACED TO A FITTING ON A PRESSURIZED HYDRAULIC LINE. NO TABLE FUNCTIONAL ISSUES WERE IDENTIFIED DURING SUBSEQUENT TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147348 ORT300 TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT300 00857534006356

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other