BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 1648460 · Received April 1, 2010

    Report

    Report Number
    1043572-2010-00017
    Date Received
    April 1, 2010
    Date of Event
    March 4, 2010
    Report Date
    April 1, 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 BRACKET WHICH HOLDS THE AUXILIARY/OVERRIDE SWITCH ON THE SHROUD COLUMN OF THE TABLE WAS BENT, CAUSING THE OVERRIDE SWITCHES TO BREAK AND THE TABLE TO MOVE INADVERTENTLY INTO THE REFLEX POSITION THE CAUSE OF THIS EVENT APPEARS TO BE MISUSE OF THE DEVICE - I.E., SETTING /STORING OBJECTS ON THE BASE OF THE TABLE - RESULTING IN DAMAGE TO THE TABLE'S ELECTRONICS, WHICH IN EXTREME CASES CAN CAUSE INADVERTENT MOVEMENT OF THE TABLE. SUCH MISUSE IS SPECIFICALLY CONTRADICTED IN THE LABELING OF (B)(4) SURGICAL TABLES AND IN STERIS TRAINING REGARDING THE DEVICE. THIS TYPE OF MISUSE IS THE OBJECT OF A VOLUNTARY FIELD CORRECTION INITIATED BY STERIS CORPORATION ON FEBRUARY 23, 2010 (REPORT #1043572-2/17/10-003C) OF 3085 SP SURGICAL TABLES. (B)(4). THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY BIOMEDICAL DEPARTMENT. THE STERIS SERVICE TECHNICIAN INSTALLED THE RIGID GUARD AND BIOMEDICAL PERSONNEL REPAIRED THE TABLE AFTER THE INCIDENT, PLACING THE TABLE BACK IN SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE SURGICAL TABLE SINCE THE REPORTED EVENT AN IN-SERVICE TRAINING FOR HOSPITAL STAFF REGARDING THE PROPER USE AND OPERATION OF THE TABLE WAS COMPLETED ON (B)(4), 2010.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A SURGICAL TABLE BEGAN MOVE INTO THE REFLEX POSITION WITHOUT BEING COMMANDED TO DO SO DURING A PATIENT PROCEDURE. THE PATIENT WAS TRANSFERRED TO A STRETCHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other