BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OR TABLE V2 (ORT100)

    MDR report key: 7026583 · Received November 13, 2017

    Report

    Report Number
    3010326005-2017-00010
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 24, 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
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE ROLL HYDRAULIC CYLINDER ON THE TABLE. THE HYDRAULIC SYSTEM WAS FLUSHED AND BLED OF AIR. THE TABLE WAS FUNCTIONALLY TESTED AFTER THE REPAIR TO VERIFY PROPER FUNCTION.

    Description of Event or Problem · 1

    THE ORT100 TABLE DRIFTED DURING A PROCEDURE. ONCE THE DRIFT WAS NOTICED, THE TABLE WAS MOVED BACK INTO PROPER POSITION AND THE CASE PROCEEDED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803291 IMRIS T2X OR TABLE V2 (ORT100) OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT100

    Patients

    Seq Age Sex Outcome Treatment
    1