BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OR TABLE V2 (ORT100)

    MDR report key: 7026574 · Received November 13, 2017

    Report

    Report Number
    3010326005-2017-00009
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 2, 2017
    Report Date
    November 13, 2017
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIFT ISSUE WAS ISOLATED BY THE SERVICE FIELD ENGINEER TO THE ROLL CYLINDER AND THE FLOW CONTROL VALVES. THEY WERE REPLACED, THE HYDRAULIC SYSTEM WAS FLUSHED AND BLED OF ANY AIR, AND TWO 8-HOUR DRIFT TESTS WERE CONDUCTED TO VERIFY PROPER FUNCTION OF THE TABLE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ORT100 TABLE EXHIBITED ROLL DRIFT ISSUES. IT WAS LATER DISCOVERED THAT A PATIENT HAD BEEN INVOLVED IN THE INCIDENT WHEN THE DRIFT IN THE ROLL CYLINDER WAS OBSERVED. THE TABLE WAS RE-LEVELED BY OR STAFF AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806180 IMRIS T2X OR TABLE V2 (ORT100) OPERATING ROOM TABLE, PRODUCT CODE KXJ KXJ IMRIS - DEERFIELD IMAGING, INC. ORT100

    Patients

    Seq Age Sex Outcome Treatment
    1