BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 14986494 · Received July 12, 2022

    Report

    Report Number
    1043572-2022-00047
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 13, 2022
    Report Date
    July 12, 2022
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN INSPECTED THE 3080SP SURGICAL TABLE AND FOUND THE SURGICAL TABLE TO BE OPERATING TO SPECIFICATION. NO EVIDENCE OF DAMAGE OR CORROSION WAS FOUND ON THE OVERRIDE SWITCHES, OVERRIDE BOARD OR MASTER CONTROL BOARD. THE SERVICE TECHNICIAN FURTHER INSPECTED THE HAND CONTROL AND STATED THAT THE HAND CONTROL CORD HAD BEEN RECENTLY REPLACED BY THE USER FACILITY. THE TECHNICIAN DISASSEMBLED THE HAND CONTROL'S HOUSING AND FOUND EVIDENCE OF CORROSION AND DRIED FLUIDS TO BE PRESENT. THE USER FACILITY REQUESTED THE 3080SP SURGICAL TABLE BE REMOVED FROM SERVICE UNTIL THEY DECIDE ON TABLE REPAIRS. STERIS HAS MADE MULTIPLE ATTEMPTS TO FOLLOW-UP WITH USER FACILITY PERSONNEL ON THE REPAIR OPTIONS HOWEVER, THE USER FACILITY HAS NOT RESPONDED. THE 3080SP SURGICAL TABLE HAS BEEN IN SERVICE FOR APPROXIMATELY 27 YEARS. STERIS IS NOT RESPONSIBLE FOR PREVENTIVE MAINTENANCE OR SERVICE ACTIVITIES FOR THE SURGICAL TABLE. THE OPERATOR MANUAL STATES (SECTION 7), "PREVENTIVE MAINTENANCE - INSPECT ELECTRICAL CORD AND HAND CONTROL CABLE. USING HAND CONTROL, CHECK TABLE POSITIONING". NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR 3080SP SURGICAL TABLE BEGAN TO MOVE INTO TREND ORIENTATION FROM REVERSE TREND POSITION WITHOUT BEING COMMANDED TO DO SO. USER FACILITY PERSONNEL ACTIVATED THE REVERSE TREND BUTTON ON THE HAND CONTROL AND THE MOVEMENT STOPPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721850 3080 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown