BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 1598818 · Received February 13, 2010

    Report

    Report Number
    1043572-2010-00003
    Date Received
    February 13, 2010
    Date of Event
    January 11, 2010
    Report Date
    February 12, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN VISUALLY EXAMINED THE TABLE. THE TECHNICIAN OBSERVED THAT THE COLUMN SHROUD WAS BENT AND SEPARATED AND THAT MULTIPLE OVERRIDE SWITCHES APPEARED TO BE BROKEN. WARNING LABELS WERE PRESENT ON THE TABLE, INCLUDING THE CAUTION NOTICE "POSSIBLE TABLE DAMAGE - DO NO USE THE TABLE BASE FOR STORAGE". STERIS HAS DETERMINED THE CAUSE OF THIS EVENT TO BE USER ERROR, IN THAT THIS HOSPITAL USES THE BASE OF THE SURGICAL TABLE FOR STORING ITEMS. STORAGE OF ITEMS ON THE TABLE BASE CAN CAUSE BENDING OF THE SHROUD, WHICH CAN RESULT IN DAMAGE TO THE TABLE OVERRIDE SWITCHES AS THE SHROUD IS PUSHED INTO THE INTERNAL COVER PLATE. IF THE TABLE OVERRIDE SWITCH IS DAMAGED IN THIS MANNER, UNDIRECTED TABLE MOVEMENT CAN OCCUR. THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY SERVICED AND MAINTAINED BY A THIRD PARTY SERVICE PROVIDER. THE THIRD PARTY SERVICE REPAIRED THE TABLE AFTER THE INCIDENT AND PLACED THE TABLE BACK IN SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE SURGICAL TABLE SINCE THE REPORTED EVENT. STERIS HAS OFFERED TO PROVIDE 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 WHILE THE SURGICAL TABLE WAS BEING LOWERED, THE HEAD AND LEG SECTION OF THE TABLE MOVED UPWARD WITHOUT BEING COMMANDED TO DO SO. THIS EVENT OCCURRED AT THE CONCLUSION OF A PROCEDURE AND THE PATIENT WAS TRANSFERRED TO A STRETCHER WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY 2151227

    Patients

    Seq Age Sex Outcome Treatment
    1 Other