BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT200 OPERATING ROOM TABLE

    MDR report key: 14739259 · Received June 17, 2022

    Report

    Report Number
    3010326005-2022-00009
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 9, 2021
    Report Date
    June 9, 2021
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    UDI-DI
    00857534006738
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN IMRIS CUSTOMER SERVICE ENGINEER WENT ON-SITE TO INVESTIGATE THE REPORTED LEAKAGE OF HYDRAULIC FLUID. THE ENGINEER OBSERVED POOLING OF HYDRAULIC FLUID INSIDE THE TABLE COVERS AND TRACED THE CAUSE OF THE LEAK TO AN O-RING BETWEEN THE TABLE'S HYDRAULIC PUMP HOUSING AND FLUID RESERVOIR. NO PATIENT INVOLVEMENT OR MALFUNCTION OF THE TABLE'S HYDRAULIC SYSTEM WAS REPORTED. THE ENGINEER REPLACED THE O-RING AND VERIFIED TABLE FUNCTION. THIS MDR IS BEING SUBMITTED OUTSIDE OF THE REQUIRED TIMEFRAME AS PART OF REMEDIAL ACTION INITIATED BY THE MANUFACTURER IN RESPONSE TO AN INTERNALLY IDENTIFIED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY OBSERVED HYDRAULIC FLUID ON THE OPERATING ROOM TABLE COVERS. NO PATIENT INVOLVEMENT OR MALFUNCTION IN THE TABLE'S OPERATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398002 IMRIS ORT200 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT200 00857534006738

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown