BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 9254969 · Received October 30, 2019

    Report

    Report Number
    1043572-2019-00093
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 30, 2019
    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 SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE 4085 SURGICAL TABLE AND CONFIRMED THE ALARM. THE "FLOOR LOCKS NOT DETECTED" ALARM INDICATES THAT THE FLOOR LOCK PRESSURE SENSOR IS NOT DETECTING THE TABLE AS LOCKED. DURING THE TECHNICIAN'S INSPECTION, HE FOUND THAT THE TABLE WAS LOCKED; HOWEVER, THE FLOOR LOCK PRESSURE SENSOR WAS DETECTING THE TABLE AS UNLOCKED INSTEAD. AS DESIGNED, THE HAND CONTROL DOES NOT ALLOW ARTICULATION OF THE SURGICAL TABLE WHEN IT IS DETECTED AS UNLOCKED. THE RESULTS OF THE TECHNICIAN'S INSPECTION ARE INDICATIVE OF AIR WITHIN THE HYDRAULIC SYSTEM. AS THE AIR COMPRESSES WITHIN THE HYDRAULIC SYSTEM, THERE IS INSUFFICIENT PRESSURE TO ACTIVATE THE FLOOR LOCK PRESSURE SENSOR CAUSING THE REPORTED ALARM. THE TECHNICIAN PERFORMED AN AIR BLEED/PURGE ON THE SURGICAL TABLE'S HYDRAULIC SYSTEM TO REMOVE ALL AIR, TESTED THE TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE 4085 SURGICAL TABLE WAS INSTALLED IN (B)(6) 2017 AND IS NOT UNDER STERIS SERVICE AGREEMENT. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. 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. THE USER FACILITY DID NOT DISCLOSE IF ANY HYDRAULIC COMPONENTS HAVE BEEN REPLACED SINCE THE INSTALLATION OF THE TABLE. THE 4085 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." A STERIS ACCOUNT MANAGER PERFORMED IN-SERVICE ON THE PROPER USE AND OPERATION OF THE 4085 SURGICAL TABLE, SPECIFICALLY PROPER MAINTENANCE ACTIVITIES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AT THE START OF THE PATIENT PROCEDURE, THE HAND CONTROL TO THEIR 4085 SURGICAL TABLE STOPPED WORKING DUE TO A "FLOOR LOCKS NOT DETECTED" ALARM. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE RESULTING IN A DELAY; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO INJURIES ASSOCIATED WITH THE REPORTED EVENT. THE USER FACILITY REPORTED THAT AT THE START OF THE PATIENT PROCEDURE, THE HAND CONTROL TO THEIR 4085 SURGICAL TABLE STOPPED WORKING DUE TO A "FLOOR LOCKS NOT DETECTED" ALARM. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE RESULTING IN A DELAY; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO INJURIES ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052718 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1