BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT300 OPERATING ROOM TABLE

    MDR report key: 7034961 · Received November 15, 2017

    Report

    Report Number
    3010326005-2017-00011
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 12, 2017
    Report Date
    December 19, 2017
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    K083137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE TABLE IN QUESTION AND CORRECTIVE ACTIONS TAKEN AS FOLLOWS: THE CUSTOMER SERVICE FIELD ENGINEER REPLACED TWO LEAKING HYDRAULIC FLOW CONTROL VALVES AND TIGHTENED A LOOSE FITTING ON ONE OF THE HYDRAULIC CYLINDERS. THE HYDRAULIC FLUID WAS FLUSHED AND A NEW FILTER INSTALLED. THE HYDRAULIC SYSTEM WAS BLED OF AIR. TESTING WAS PERFORMED ON THE TABLE TO VERIFY PROPER FUNCTION. THE TABLE OPERATES WITHIN SPECIFICATION. INTERNAL (B)(4) WAS ISSUED.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER INVESTIGATED THIS INCIDENT ON OCTOBER 27, 2017. HE INSPECTED THE TABLE AND TESTED IT FOR DRIFT. HE WAS UNABLE TO VERIFY THE DRIFT SYMPTOMS. AFTER HE REMOVED THE COVERS OF THE TABLE, HE OBSERVED SOME SMALL HYDRAULIC FLUID LEAKAGE FROM THE MANIFOLD AREA. THIS COULD POTENTIALLY BE THE UNDERLYING CAUSE OF THE DRIFT. THE FIELD SERVICE ENGINEER WILL BE REPLACING THE LEAKING HYDRAULIC COMPONENT(S) AND PERFORMING FUNCTIONAL TESTING TO VERIFY PROPER OPERATION AFTER THE REPAIR HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PROCEDURE HAD BEEN SUCCESSFULLY PERFORMED AND MR IMAGING WAS COMPLETED. HOSPITAL PERSONNEL WERE MOVING THE MAGNET AWAY FROM THE TABLE WHEN THEY NOTICED CONTACT BETWEEN THE HEAD FIXATION DEVICE, WHICH WAS ATTACHED TO THE TABLE, AND THE BORE OF THE MAGNET. THIS CONTACT WAS NOT EVIDENT WHEN THE MAGNET WAS INITIALLY MOVED OVER THE TABLE AND THEY ASSUMED THAT THE TABLE DRIFTED SLIGHTLY DOWNWARD. THEY LIFTED UP ON THE BACK SECTION OF THE TABLE A SMALL AMOUNT TO ELIMINATE THE CONTACT AND THEN CONTINUED MOVING THE MAGNET AWAY FROM THE TABLE. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 1

    THE PROCEDURE HAD BEEN SUCCESSFULLY PERFORMED AND MR IMAGING WAS COMPLETED. HOSPITAL PERSONNEL WERE MOVING THE MAGNET AWAY FROM THE TABLE WHEN THEY NOTICED CONTACT BETWEEN THE HEAD FIXATION DEVICE, WHICH WAS ATTACHED TO THE TABLE, AND THE BORE OF THE MAGNET. THIS CONTACT WAS NOT EVIDENT WHEN THE MAGNET WAS INITIALLY MOVED OVER THE TABLE AND THEY ASSUMED THAT THE TABLE DRIFTED SLIGHTLY DOWNWARD. THEY LIFTED UP ON THE BACK SECTION OF THE TABLE A SMALL AMOUNT TO ELIMINATE THE CONTACT AND THEN CONTINUED MOVING THE MAGNET AWAY FROM THE TABLE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814474 IMRIS ORT300 OPERATING ROOM TABLE RADIOLOGIC TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT300

    Patients

    Seq Age Sex Outcome Treatment
    1