BEUDAMED
    FDA Adverse Event Summary report: N

    3080RL SURGICAL TABLE

    MDR report key: 4931835 · Received July 22, 2015

    Report

    Report Number
    1043572-2015-00067
    Date Received
    July 22, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 22, 2015
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE SURGICAL TABLE, AND IDENTIFIED THE SHROUD BRACKET WAS BENT AT THE CORNER. THE HYDRAULIC HOSE NEAREST THE BENT BRACKET WAS SLICED ON THE OUTER SURFACE WHICH WAS THE SOURCE OF THE HYDRAULIC LEAK. THE TECHNICIAN WAS INFORMED THAT ITEMS WERE PRESENT ON THE TABLE BASE AND DAMAGED THE COLUMN SHROUD. THE SHROUD BENT INTO A POSITION WHICH DAMAGED THE HYDRAULIC HOSE CAUSING A LEAK OF FLUID. THE LACK OF HYDRAULIC FLUID ALLOWED FOR THE TABLE TO MALFUNCTION AND DROP AS REPORTED BY THE USER FACILITY. SECTION 1 OF THE MAINTENANCE MANUAL STATES, "WARNING - PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: STORING ITEMS ON TABLE BASE MAY RESULT IN EQUIPMENT DAMAGE CAUSING INADVERTENT TABLETOP MOVEMENT PLACING PATIENT AND/OR USER AT RISK OF PERSONAL INJURY. DO NOT USE TABLE BASE FOR STORAGE." THE TECHNICIAN CONFIRMED THE WARNING LABEL WAS PRESENT ON THE SURGICAL TABLE'S BASE WHICH STATES, "WARNING! PERSONAL INJURY HAZARD/EQUIPMENT DAMAGE. STORING ITEMS ON TABLE BASE MAY RESULT IN EQUIPMENT DAMAGE CAUSING INADVERTENT TABLETOP MOVEMENT PLACING THE PATIENT AND/OR USER AT RISK OF PERSONAL INJURY. DO NOT STEP ON OR STORE ITEMS ON BASE!" THE TECHNICIAN STRAIGHTENED THE SHROUD BRACKET, REPLACED THE HYDRAULIC HOSE, AND REFILLED THE HYDRAULIC RESERVOIR. THE TABLE WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE TECHNICIAN DISCUSSED THE IMPORTANCE OF KEEPING THE BASE AREA CLEAR OF OBSTRUCTIONS WITH THE USER FACILITY STAFF.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THEIR 3080RL SURGICAL TABLE WAS LEAKING HYDRAULIC FLUID AND THE BACK SECTION BEGAN TO DROP. THE PATIENT WAS TRANSFERRED TO ANOTHER SURGICAL TABLE WHERE THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO REPORT OF INJURY. A PROCEDURAL DELAY WAS REPORTED DUE TO THE PATIENT TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477660 3080RL SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1