BEUDAMED
    FDA Adverse Event Summary report: N

    3080 SR SURGICAL TABLE

    MDR report key: 1951372 · Received January 6, 2011

    Report

    Report Number
    1043572-2011-00002
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 6, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE TABLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT; ALL TABLE FUNCTIONS WERE FOUND TO BE OPERATING PROPERLY. AS A PRECAUTION, THE TECHNICIAN REPLACED THE HAND CONTROL, OVERRIDE BOARD ASSEMBLY, AND OVERRIDE CABLE. THE TABLE HAS BEEN PLACED BACK INTO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS TABLE. THE TABLE SUBJECT OF THIS EVENT IS 16 YEARS OLD AND EXCEEDS ITS USEFUL LIFE OF 10 YEARS; STERIS WILL RECOMMEND THAT THE TABLE BE REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE TABLE WENT INTO TRENDELENBURG POSITION WITHOUT BEING COMMANDED TO DO SO. THE OPERATOR WAS ABLE TO STOP THE MOVEMENT BY COMMANDING "LEVEL" ON THE HAND CONTROL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO INJURIES WERE REPORTED TO HOSPITAL STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3080 SR SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1