BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OPERATING ROOM TABLE

    MDR report key: 13506947 · Received February 10, 2022

    Report

    Report Number
    3010326005-2019-00015
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    July 3, 2019
    Report Date
    July 3, 2019
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN IMRIS CUSTOMER SERVICE ENGINEER (CSE) WAS ONSITE TO RESOLVE THE ISSUE. UPON ARRIVAL, THE CSE NOTICED THAT THE T2X OPERATING ROOM TABLE SHOWED SIGNS OF UNWEIGHTED HEAD UP TRENDELENBURG DRIFTING AFTER FOUR DAYS OF BEING UNTOUCHED. THE TABLE WAS INSPECTED FOR HYDRAULIC FLUID LEAKS AND LOOSE CONNECTIONS AND A FITTING WAS FOUND THAT MAY HAVE ALLOWED AIR INTO THE HYDRAULIC LINES. THE FITTING WAS SECURED AND AIR WAS BLED FROM THE TABLE HYDRAULIC SYSTEM. DRIFT TESTING WAS PERFORMED AND RESULTS PASSED, AND NO EVIDENCE OF AIR IN THE HYDRAULIC LINES WAS OBSERVED AFTER ADJUSTING THE HYDRAULIC FITTING. THIS MDR IS BEING SUBMITTED OUTSIDE OF THE REQUIRED TIMEFRAME AS PART OF REMEDIAL ACTION INITIATED BY THE MANUFACTURER, IN RESPONSE TO INTERNALLY IDENTIFIED ISSUES REGARDING FAILED ELECTRONIC SUBMISSIONS THROUGH WEBTRADER.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THE CUSTOMER OBSERVED DRIFT IN THE T2X OPERATING ROOM TABLE. THE EVENT OCCURRED DURING DAILY QA AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544452 IMRIS T2X OPERATING ROOM TABLE OPERATING ROOM TABLE FQO IMRIS - DEERFIELD IMAGING, INC T2X (ORT100)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown