BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 14162037 · Received April 20, 2022

    Report

    Report Number
    1043572-2022-00032
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 23, 2022
    Report Date
    April 20, 2022
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE AND WAS UNABLE TO RECREATE THE REPORTED EVENT. UPON INSPECTION, THE TECHNICIAN FOUND THAT THE TABLE HAND CONTROL HOUSING WAS DAMAGED. THE TABLE IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TABLE WAS INSTALLED IN (B)(6) 1996 MAKING IT APPROXIMATELY 25 YEARS OLD AT THE TIME OF THE REPORTED EVENT. THE TECHNICIAN REPLACED THE DAMAGED HAND CONTROL, TESTED THE TABLE, CONFIRMED IT WAS OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272645 3080 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown