BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS

    MDR report key: 7032723 · Received November 15, 2017

    Report

    Report Number
    7032723
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 25, 2017
    Manufacturer
    IMRIS-DEERFIELD IMAGING, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER INTUBATION AND PRIOR TO INCISION, THE BED IN THE OR COLLAPSED. THE BED TILTED HEAD DOWN WHILE THE PATIENT WAS ON THE BED. THE BED AND PATIENT WERE IMMEDIATELY PICKED UP AND THE PATIENT WAS TRANSFERRED TO A STRETCHER. THE PATIENT WAS TAKEN BY STRETCHER INTO THE GARAGE FOR AN MRI. THE SURGERY WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814784 IMRIS TABLE, OPERATING-ROOM, AC-POWERED FQO IMRIS-DEERFIELD IMAGING, INC. T2X

    Patients

    Seq Age Sex Outcome Treatment
    1