BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 1651928 · Received April 6, 2010

    Report

    Report Number
    1043572-2010-00019
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 8, 2010
    Report Date
    April 6, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THE HAND CONTROL WAS NOT FUNCTIONING PROPERLY. THE TECHNICIAN REPLACED THE HAND CONTROL AND PLACED THE TABLE BACK INTO SERVICE. THE HAND CONTROL IS NOT AVAILABLE FOR EVALUATION AS THE USER FACILITY SENT IT TO A THIRD PARTY FOR REFURBISHING. THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY BIOMEDICAL DEPARTMENT. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE SURGICAL TABLE SINCE THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE SURGICAL TABLE WOULD NOT MOVE INTO THE TRENDELENBURG POSITION WHEN COMMANDED TO DO SO AND THE TABLE MOVEMENTS BECAME "JERKY". THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO INJURY WAS REPORTED TO EITHER THE PATIENT OR THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY 3085SP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other