BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 RL SURGICAL TABLE

    MDR report key: 9265766 · Received November 1, 2019

    Report

    Report Number
    1043572-2019-00094
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 1, 2019
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3080 RL SURGICAL TABLE WAS INSTALLED IN 1992, MAKING THE UNIT APPROXIMATELY 27 YEARS OLD AT THE TIME OF THE REPORTED EVENT. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE 3080RL SURGICAL TABLE. THE TECHNICIAN COULD NOT REPRODUCE THE REPORTED DRIFT. THE TECHNICIAN PERFORMED AN AIR BLEED/PURGE ON THE SURGICAL TABLE'S HYDRAULIC SYSTEM, TESTED THE TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED THE TABLE TO SERVICE. DURING THE TIME OF THE REPORTED EVENT, THE 3080RL SURGICAL WAS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE BIOMED DEPARTMENT WAS RESPONSIBLE FOR ALL MAINTENANCE. THE USER FACILITY HAS ELECTED TO ENROLL UNDER A STERIS SERVICE AGREEMENT DUE TO THE REPORTED EVENT. DURING MAINTENANCE ACTIVITIES SUCH AS REPLACING HYDRAULIC COMPONENTS, AIR CAN ENTER THE HYDRAULIC SYSTEM AS HYDRAULIC FLUID LEAKS OUT. THE AIR BLEED/PURGE PROCESS SHOULD BE PERFORMED AFTER REPLACEMENT OF HYDRAULIC COMPONENTS TO ENSURE NO AIR REMAINS IN THE HYDRAULIC SYSTEM. USER FACILITY PERSONNEL WERE NOT ABLE TO CONFIRM WHETHER OR NOT ANY OF THE HYDRAULIC COMPONENTS WITHIN THE 3080 RL SURGICAL TABLE HAD BEEN REPLACED WHILE NOT UNDER STERIS SERVICE AGREEMENT. THE 3080 RL SURGICAL TABLE OPERATOR MANUAL STATES, "WARNING - PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: REPAIRS AND ADJUSTMENTS TO THIS EQUIPMENT MUST BE MADE ONLY BY STERIS OR STERIS-TRAINED SERVICE PERSONNEL. MAINTENANCE PERFORMED BY UNQUALIFIED PERSONNEL OR INSTALLATION OF UNAUTHORIZED PARTS COULD CAUSE PERSONAL INJURY, RESULT IN IMPROPER EQUIPMENT PERFORMANCE, INVALIDATE THE WARRANTY, OR RESULT IN COSTLY DAMAGE. CONTACT STERIS REGARDING SERVICE OPTIONS." WHILE ONSITE, THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND MAINTENANCE OF THE 3080 RL SURGICAL TABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WITH THE PATIENT POSITIONED IN REVERSE TREND, THEIR 3080 RL SURGICAL TABLE BEGAN TO DRIFT TOWARDS THE FLEX POSITION. A PROCEDURE DELAY OCCURRED AS USER FACILITY PERSONNEL HAD TO REPOSITION THE PATIENT AND THE SURGICAL TABLE. NO REPORT OF INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059374 3080 RL SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1