BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 1718971 · Received June 11, 2010

    Report

    Report Number
    1043572-2010-00045
    Date Received
    June 11, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 10, 2010
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THAT THERE WAS A SEQUENTIAL COMPRESSION DEVICE (SCD) BEING STORED ON THE TABLE BASE. THE TABLE SHROUDS MADE CONTACT WITH THE SCD WHEN THE TABLE WAS BEING LOWERED AND PUSHED THE SHROUD INTO THE OVERRIDE SWITCHES CAUSING THEM TO SHORT OUT. THE CAUSE OF THIS EVEN 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 3085 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 # 104357-22/17/10-003C) OF 3085 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 A THIRD PARTY. THE STERIS SERVICE TECHNICIAN INSTALLED THE RIGID GUARD, NEW SHROUD SUPPORT BRACKETS AND OVERRIDE SWITCHES, PLACING THE TABLE BACK IN SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE SURGICAL TABLE SINCE THE REPORTED EVENT. WARNING LABELS WERE PRESENT ON THE TABLE, INCLUDING "POSSIBLE TABLE DAMAGE - DO NOT USE THE TABLE BASE FOR STORAGE" AND THE TECHNICIAN INFORMED HOSPITAL STAFF OF THE IMPORTANCE OF NOT STORING ITEMS ON THE TABLE BASE. STERIS CONDUCTED REFRESHER IN-SERVICE TRAINING FOR THE FACILITY REGARDING THE PROPER OPERATION, USE, AND ASSOCIATED WARNINGS OF THE SURGICAL TABLE ON (B)(6), 2010.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PRIOR TO A PATIENT BEING PLACED ON THE SURGICAL TABLE, AN OR ASSISTANT WAS PREPARING TO ADJUST THE TABLE AND FOUND THERE WAS NO POWER TO THE TABLE. NO INJURIES WERE REPORTED.

    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