BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3085 SP SURGICAL TABLE

    MDR report key: 16764098 · Received April 18, 2023

    Report

    Report Number
    1043572-2023-00088
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    December 17, 2022
    Report Date
    April 18, 2023
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY MEDWATCH INDICATED THIS EVENT OCCURRED ON (B)(6) 2022. A REVIEW OF OUR SERVICE RECORDS INDICATES THERE WERE NO REQUESTS FOR SERVICE RECEIVED FROM THE CUSTOMER SINCE (B)(6) 2021. ON JANUARY 26, 2023, A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO PERFORM SCHEDULED PREVENTIVE MAINTENANCE VISITS AND OBSERVED THE 3085 SP SURGICAL TABLE HAD A NOTE WHICH STATES "TABLE DOES NOT LOCK". AT THIS TIME, THE TECHNICIAN WAS NOT INFORMED OF ANY PATIENT OR PROCEDURE INVOLVEMENT RELATED TO THIS SERVICE VISIT. WHILE ONSITE, THE TECHNICIAN INSPECTED THE TABLE AND FOUND NO ISSUE WITH THE TABLE. NO REPAIRS WERE REQUIRED AND THE TABLE WAS RETURNED TO SERVICE. THE TABLE WAS INSTALLED IN 2005 MAKING IT APPROXIMATELY 18 YEARS OLD. BASED ON THE TECHNICIAN'S INSPECTION RESULTS, THE REPORTED EVENT IS LIKELY ATTRIBUTED TO THE TABLE BEING UNPLUGGED AT THE END OF THE PROCEDURE WHEN THE TABLE WAS MOVED. THIS IS AN AC POWER ONLY TABLE AND IT WILL LOSE POWER IF IT IS UNPLUGGED. THE 3085 SP SURGICAL TABLE OPERATOR MANUAL STATES (7-1), "NO POWER TO PUMP MOTOR; TABLE WILL NOT ARTICULATE. - POSSIBLE CAUSE AND CORRECTIVE ACTION 1. TABLE UNPLUGGED (ELECTRIC-POWERED TABLE ONLY)-PLUG IN." THE 3085 SP SURGICAL TABLE IS EQUIPPED WITH AUXILIARY OVERRIDE SYSTEM WHICH CAN BE ACTIVATED IN THE EVENT OF LOSS OF PRIMARY HAND CONTROL FUNCTION. THE 3085 SP SURGICAL TABLE OPERATOR MANUAL STATES (5-1), "THE AMSCO 3085 SP SURGICAL TABLE IS EQUIPPED WITH AUXILIARY OVERRIDE SYSTEMS THAT CAN BE ACTUATED AT ANY TIME AND THAT WILL ALLOW TABLE OPERATION IN THE EVENT OF PRIMARY CONTROL MALFUNCTION. ARTICULATE TABLE ACCORDING TO THE PROCEDURES IN SECTION 5.1, ARTICULATION WITH ELECTRIC PUMP POWER AVAILABLE, OR ACCORDING TO THE PROCEDURES IN SECTION 5.2, ARTICULATION WITH NO ELECTRIC PUMP POWER AVAILABLE, IF NO PUMP POWER IS AVAILABLE. OPERATE THE FLOOR LOCK AUXILIARY OVERRIDE SYSTEMS ACCORDING TO THE PROCEDURES IN SECTION 5.3, FLOOR LOCK OVERRIDE SYSTEMS." A STERIS ACCOUNT MANAGER OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE 3085 SP SURGICAL TABLE, SPECIFICALLY ENSURING THE TABLE IS PLUGGED IN AND USE OF THE AUXILIARY OVERRIDE SYSTEM; WE ARE PENDING A RESPONSE FROM THE USER FACILITY.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT (B)(4), AT THE END OF A PATIENT PROCEDURE WHEN TRYING TO MOVE THEIR 3085 SP SURGICAL TABLE OVER TO THE PATIENT'S BED FOR PATIENT TRANSFER, THEIR 3085 SP SURGICAL TABLE HAND CONTROL STOPPED WORKING AND THE TABLE COULD NOT BE RELOCKED. THE PATIENT WAS SUCCESSFULLY TRANSFERRED OVER TO ANOTHER BED FROM THE UNLOCKED TABLE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624433 3085 SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown