BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T@X OR TABLE V2 (ORT100)

    MDR report key: 7123452 · Received December 15, 2017

    Report

    Report Number
    3010326005-2017-00013
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 28, 2017
    Report Date
    July 14, 2018
    Manufacturer
    IMRIS-DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER SERVICE ENGINEER REPLACED THE HYDRAULIC COMPONENTS, FLUSHED THE SYSTEM AND TESTED THE TABLE TO VERIFY PROPER FUNCTION.

    Description of Event or Problem · 0

    3-4 HOURS INTO AN AWAKE CRANIOTOMY PROCEDURE, THE SURGEON NOTICED THAT THE PATIENT WAS NOT FLAT. THE ORT100 TABLE HAD DRIFTED SLIGHTLY TO THE RIGHT SIDE. THE OPERATING ROOM PERSONNEL COUNTERBALANCED THE TABLE IN ORDER TO PROCEED. THERE WERE NO INJURIES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE ORT100 TABLE IS IN THE PROCESS OF BEING EVALUATED . A FOLLOW-UP REPORT SHALL BE SUBMITTED TO FDA WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, IT WAS REPORTED THAT, 3-4 HOURS INTO AN AWAKE CRANIOTOMY PROCEDURE, THE SURGEON NOTICED THAT THE PATIENT WAS NOT FLAT. THE ORT100 OPERATING ROOM TABLE HAD DRIFTED SLIGHTLY TO THE RIGHT SIDE. THEY COUNTERBALANCED THE TABLE IN ORDER TO PROCEED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO INJURIES SUSTAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902530 IMRIS T@X OR TABLE V2 (ORT100) OPERATING ROOM TABLE KXJ IMRIS-DEERFIELD IMAGING, INC. ORT100

    Patients

    Seq Age Sex Outcome Treatment
    1