BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 16509291 · Received March 8, 2023

    Report

    Report Number
    1043572-2023-00058
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 8, 2023
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 3080SP SURGICAL TABLE SUBJECT OF THE REPORTED EVENT IS APPROXIMATELY 27 YEARS OLD. A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE FOLLOWING THE REPORTED EVENT AND FOUND NO ISSUES WITH THE FUNCTION OR OPERATION. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT AND CONFIRMED THE SURGICAL TABLE TO BE OPERATING PROPERLY. THE TECHNICIAN RETURNED THE 3080SP SURGICAL TABLE TO SERVICE AND 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 LOWERED IN HEIGHT WITHOUT BEING COMMANDED TO DO SO. THE PATIENT WAS TRANSFERRED TO A DIFFERENT SURGICAL TABLE SUBSEQUENTLY CAUSING A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707182 3080 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown