BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 RL SURGICAL TABLE

    MDR report key: 8674225 · Received June 6, 2019

    Report

    Report Number
    1043572-2019-00042
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 6, 2019
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Adverse Event
    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 FOLLOWING THE REPORTED EVENT TO INSPECT THE 3080RL SURGICAL TABLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. UPON FURTHER INSPECTION THE TECHNICIAN NOTICED THE SURGICAL TABLE'S HAND CONTROL'S LED LIGHTS WOULD FLASH WHEN HE MOVED OR FLEXED THE HAND CONTROL'S CORD. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE HAND CONTROL. THE HAND CONTROL HAD BECOME WORN OVER TIME, CAUSING AN INADEQUATE CONNECTION BETWEEN THE HAND CONTROL AND SURGICAL TABLE. THE HAND CONTROL WAS REMOVED FROM SERVICE AND WAS REPLACED. THE TECHNICIAN TESTED THE SURGICAL TABLE, FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATION AND RETURNED IT TO SERVICE. IT IS IMPORTANT TO NOTE THE 3080RL SURGICAL TABLE'S HAND CONTROLS ARE INTERCHANGEABLE. THE FACILITY IS ABLE TO DISCONNECT ONE HAND CONTROL FROM A SURGICAL TABLE AND MOVE IT TO ANOTHER AS DESIRED. THE 3080RL SURGICAL TABLE WAS INSTALLED IN 1993 MAKING THE UNIT APPROXIMATELY 25 YEARS OLD AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE FACILITY'S BIOMED DEPARTMENT IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. WHILE ONSITE, THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND MAINTENANCE OF THE 3080RL SURGICAL TABLE AND ITS ACCESSORIES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR 3080RL SURGICAL TABLE BEGAN TO MOVE INTO THE FLEX POSITION WITHOUT BEING COMMANDED TO DO SO DURING A PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467871 3080 RL SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1