BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 1616677 · Received February 26, 2010

    Report

    Report Number
    1043572-2010-00006
    Date Received
    February 26, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 26, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. HOWEVER THE TECHNICIAN DID FIND THE POWER CORD COVERING WAS TORN, EXPOSING ELECTRICAL WIRES, DUE TO THE SURGICAL TABLE BEING REPEATEDLY ROLLED OVER THE CORD. IN ADDITION THE TECHNICIAN FOUND THE TABLE COLUMN COVER ATTACHING HOOKS WERE BENT, WHICH CAUSED THE COVERS TO COLLAPSE AND POSSIBLY INTERFERE WITH THE ELECTRICAL COMPONENTS IN THE TABLE COLUMN. UPON VISUAL INSPECTION DURING A SUBSEQUENT VISIT THE TECHNICIAN DID FIND THE COLUMN SHROUD WAS DAMAGED. WARNING LABELS WERE PRESENT ON THE TABLE, INCLUDING "POSSIBLE TABLE DAMAGE - DO NOT USE THE TABLE BASE FOR STORAGE". 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 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 # 1043572-2/17/10-003C) OF 3085 SP 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 SET OR STORED ON THE BASE OF THE TABLE. 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 STERIS HAS OFFERED TO PROVIDE AN IN-SERVICE TRAINING TO HOSPITAL STAFF REGARDING THE PROPER USE AND OPERATION OF THE TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AT THE COMPLETION OF A PATIENT PROCEDURE THE SURGICAL TABLE MOVED UPWARD WHEN IT WAS COMMANDED TO MOVE DOWNWARD. ALSO, ONE OF THE BASE COVERS CAME OFF CAUSING THE OTHER BASE COVERS TO COLLAPSE. 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