BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080RL SURGICAL TABLE

    MDR report key: 9541002 · Received January 2, 2020

    Report

    Report Number
    1043572-2020-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 3, 2019
    Report Date
    January 2, 2020
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE FOLLOWING THE REPORTED EVENT TO INSPECT THE 3080RL SURGICAL TABLE AND COULD NOT DUPLICATE THE REPORTED EVENT. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE SURGICAL TABLE WERE IDENTIFIED. THE 3080RL SURGICAL TABLE WAS INSTALLED IN DECEMBER 1992, MAKING THE TABLE APPROXIMATELY 27 YEARS OLD. THE 3080RL SURGICAL TABLE HAS A STATED USEFUL LIFE OF 10 YEARS. STERIS HAS PROVIDED THE CUSTOMER A QUOTE FOR A NEW TABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE LEG SECTION OF THEIR 3080RL SURGICAL TABLE SLOWLY DRIFTED DOWNWARD WITHOUT BEING COMMANDED TO DO SO. THE USER FACILITY USED THE HAND CONTROL TO RE-POSITION THE TABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4665 3080RL SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1