BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 7584016 · Received June 8, 2018

    Report

    Report Number
    1043572-2018-00044
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 9, 2018
    Report Date
    June 8, 2018
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF PROCEDURE DELAY OR CANCELLATION. THE SURGICAL TABLE IS APPROXIMATELY 23 YEARS OLD AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE FACILITY'S BIOMED DEPARTMENT IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE 3080SP OPERATOR MANUAL STATES (PG. 6-1), "WARNING - PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: SAFE AND RELIABLE OPERATION OF THIS EQUIPMENT REQUIRES REGULARLY SCHEDULED PREVENTIVE MAINTENANCE, IN ADDITION TO THE REGULAR ROUTINE MAINTENANCE. CONTACT STERIS TO SCHEDULE." A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE SURGICAL TABLE. THE TECHNICIAN TESTED THE TABLE'S FUNCTION AND ARTICULATIONS AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. BASED ON THE DESCRIPTION OF THE REPORTED EVENT BY THE USER FACILITY IT APPEARS A DOWNWARD DRIFT OCCURRED. IF THE TABLE DOES EXPERIENCE A DRIFT THE CORRECT METHOD IS TO RE-ENERGIZE THE HYDRAULIC SYSTEM BY TURNING ON THE HAND CONTROL AND REPEATING THE DESIRED MOVEMENT/ARTICULATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE 3080SP SURGICAL TABLE LOWERED IN HEIGHT WITHOUT BEING COMMANDED TO DO SO. USER FACILITY PERSONNEL UTILIZED THE TABLE'S AUXILIARY OVERRIDE CONTROLS AND PLACED THE TABLE INTO THE DESIRED POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426888 3080 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1