BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT 1100 SURGICAL TABLE

    MDR report key: 11078547 · Received December 28, 2020

    Report

    Report Number
    1043572-2020-00066
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 28, 2020
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE OT 1100 SURGICAL TABLE AND WAS ABLE TO DUPLICATE THE REPORTED EVENT. WHILE ONSITE, THE TECHNICIAN WAS INFORMED BY USER FACILITY PERSONNEL THAT THEY WERE USING NON-STERIS HYDRAULIC OIL IN THE TABLE SUBJECT OF THE EVENT. THE OT 1100 SURGICAL TABLE OPERATOR MANUAL STATES (1-3), "CAUTION - POSSIBLE EQUIPMENT DAMAGE: USE OF INCORRECT HYDRAULIC OIL MAY SEVERELY DAMAGE THE TABLE AND/OR CAUSE MALFUNCTION. CONTACT STERIS FOR PROPER HYDRAULIC OIL." THE TABLE WAS INSTALLED IN 2017 AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN REPLACED THE HYDRAULIC OIL, MAIN HYDRAULIC MANIFOLD, AND TREND CYLINDER. THE TECHNICIAN TESTED THE TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR OT 1100 SURGICAL TABLE DRIFTED SLOWLY TOWARDS REVERSE TRENDELENBURG WITHOUT BEING COMMANDED TO DO SO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539654 OT 1100 SURGICAL TABLE SURGICAL TABLE JEA STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1