BEUDAMED
    FDA Adverse Event Summary report: N

    5085 SURGICAL TABLE

    MDR report key: 4936404 · Received July 23, 2015

    Report

    Report Number
    1043572-2015-00068
    Date Received
    July 23, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE TABLE, AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE TABLE PERFORMED NORMAL ARTICULATIONS AND FUNCTIONS WHEN TESTED. NO ISSUES WERE IDENTIFIED. THE TECHNICIAN WAS NOTIFIED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS LIKELY THAT AN OBJECT USED IN THE PROCEDURE OBSTRUCTED THE TABLE FROM ARTICULATING FULLY. IF THE LEG SECTION OF THE TABLE WAS CAUGHT ON AN OBJECT, THE FLOOR LOCK FEET WOULD LIFT FROM THE GROUND DUE TO THE POWERED MOVEMENT. THIS WAS DUPLICATED UPON FURTHER INVESTIGATION WHEN STERIS ENGINEERING EVALUATED THE TABLE. THE TABLE COULD CONTINUE TO ARTICULATE PAST THE OBSTRUCTION AND THE FLOOR LOCK FEET WOULD FALL BACK DOWN TO THE GROUND WHICH CREATED THE LOUD NOISE AS THE USER FACILITY REPORTED. SECTION 1 OF THE OPERATOR MANUAL FOR THE 5085 SURGICAL TABLE STATES, "DO NOT STORE ITEMS ON TABLE BASE. DOING SO MAY RESULT IN EQUIPMENT DAMAGE OR INADVERTENT TABLETOP MOVEMENT THAT COULD PLACE THE PATIENT AND/OR USER AT RISK OF INJURY," AND "FAILURE TO KEEP ALL PERSONNEL AND EQUIPMENT CLEAR OF THE TABLE BEFORE ARTICULATION COULD RESULT IN TABLE DAMAGE." A TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE TABLE, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. THE SURGICAL TABLE WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THEIR 5085 SURGICAL TABLE WAS IN NORMAL ORIENTATION WHEN HOSPITAL PERSONNEL COMMANDED IT TO MOVE INTO A SLIGHT REVERSE TRENDELENBURG POSITION. THE TABLE MOVED INTO POSITION AND THE USER FACILITY STAFF REPORTED HEARING A LOUD NOISE. THE TABLE'S HEIGHT DROPPED SLIGHTLY, THE FOOT SECTION DROPPED SLIGHTLY, AND THE HEAD SECTION PIVOTED UPWARD. THE USER FACILITY STAFF LEVELED THE TABLE, TRANSFERRED THE PATIENT TO ANOTHER TABLE, AND REMOVED THE TABLE SUBJECT OF THE REPORTED EVENT FROM SERVICE. NO REPORT OF INJURY. A PROCEDURAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480970 5085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1