BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 1634202 · Received March 18, 2010

    Report

    Report Number
    1043572-2010-00014
    Date Received
    March 18, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 18, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED WHEN THE SURGICAL TABLE WAS COMMANDED TO LOWER, THE LEG SECTION MOVED UPWARD AND THE TABLE MOVED INTO A LEFT TILT POSITION. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO A STRETCHER; THERE WERE NO INJURIES TO THE PATIENT OR HOSPITAL STAFF. THE FACILITY'S BIOMEDICAL PERSONNEL INSPECTED THE TABLE AFTER THE INCIDENT AND FOUND THAT THE BRACKET WHICH HOLDS THE AUXILIARY SWITCH ON THE SHROUD COLUMN OF THE TABLE WAS BENT, CAUSING THE SWITCHES TO BREAK AND THE TABLE TO MOVE INADVERTENTLY. BIOMEDICAL PERSONNEL REPLACED THE SWITCHES AND STRAIGHTENED THE BRACKET. THE FACILITY'S BIOMEDICAL PERSONNEL BELIEVE THE DAMAGED BRACKET WAS DUE TO AN UNKNOWN MANUFACTURER'S PORTABLE X-RAY MACHINE IMPACTING AND DAMAGING THE AUXILIARY SWITCHES WHILE STORED ON OR NEAR THE TABLE. 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 CONTRAINDICATED IN THE LABELING OF AMSCO 3085SP 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 (B)(4) 2010 (REPORT #1043572-2/17/10-003-C) OF 3085SP SURGICAL TABLES. AS PART OF THE FIELD CORRECTION, STERIS DEVELOPED AND IS INSTALLING A RIGID GUARD ON ALL TABLES THAT PROTECTS THE ELECTRONIC SWITCH ASSEMBLY FROM CONTACT WITH TABLE COMPONENTS THAT CAN BECOME DAMAGED AND IMPINGE THE SWITCH ASSEMBLY AS A RESULT OF ITEMS BEING IMPROPERLY STORED ON THE BASE OF THE TABLE. THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTACT 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.

    Description of Event or Problem · 1

    (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other