BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OR TABLE V2 (ORT100)

    MDR report key: 6407104 · Received March 15, 2017

    Report

    Report Number
    3010326005-2017-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    March 8, 2017
    Report Date
    March 15, 2017
    Manufacturer
    IMRIS-DEERFIELD IMAGING, INC.
    Product Code
    FQO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD AND PREVENTIVE MAINTENANCE RECORDS FOR THIS OR TABLE WERE REVIEWED WITH NO DISCREPANCIES OBSERVED. THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND OBSERVED THAT THE ROTATIONAL LOCK MECHANISM ON THE OR TABLE WAS OF AN OLDER DESIGN AND HAD NOT BEEN UPDATED. THE BOLT TO SECURE THE ROTATIONAL LOCK MECHANISM WAS BACKED OUT AND LOOSE, MOST LIKELY A RESULT OF INSUFFICIENT TIGHTENING, VIBRATIONS, OR SOME OTHER MOVEMENT OCCURRING OVER TIME, ALLOWING THE TABLE TO MOVE BEYOND IT'S SPECIFIED RANGE. THE ROTATIONAL LOCK MECHANISM WAS REMOVED AND REPLACED. THE TABLE WAS THEN TESTED TO VERIFY STABILITY AND FUNCTIONALITY. NOTE: THE 510(K) NUMBER IN THE REPORT IS N/A BECAUSE THE ORT100 TABLE IS 510(K) EXEMPT. CODE: FQO; NUMBER: 878.4960.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PROCEDURE BEGAN AT 8 AM AND EXCESS MOVEMENT OF THE ORT100 OPERATING ROOM TABLE OCCURRED AT APPROXIMATELY 3:00 PM. SURGEONS HAD BEEN LEANING ON/ACROSS THE TABLE DURING THE ENTIRE CASE. ONE SURGEON WAS LEANING ON THE TABLE ON ONE SUCH INSTANCE AND FELT IT MOVE 3-4 INCHES. THE TABLE WAS UNLOCKED, ROTATED, AND LOCKED AGAIN. THE SURGEON LEANED ON THE TABLE TO TEST AND THE EXCESS MOVEMENT OCCURRED AGAIN. ONCE MORE THE TABLE WAS UNLOCKED, ROTATED, RE-LOCKED, AND LEANED ON - THE EXCESS MOVEMENT OCCURRED AGAIN. THE SURGEONS ELECTED TO CONTINUE WITH THE PROCEDURE BUT TOOK CARE NOT TO LEAN ON THE TABLE FOR THE REMAINDER OF THE PROCEDURE. THE OUTCOME WAS SUCCESSFUL WITH NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187998 IMRIS T2X OR TABLE V2 (ORT100) OPERATING ROOM TABLE FQO IMRIS-DEERFIELD IMAGING, INC. ORT100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO