BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080SP SURGICAL TABLE

    MDR report key: 7786569 · Received August 15, 2018

    Report

    Report Number
    1043572-2018-00064
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 3, 2018
    Report Date
    August 15, 2018
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICAL TABLE WAS INSTALLED AT THE CUSTOMER'S LOCATION IN 1995 AND HAS BEEN IN USE FOR APPROXIMATELY 23 YEARS. IT IS NOT UNDER STERIS SERVICE AGREEMENT. THE USER FACILITY'S BIOMED DEPARTMENT IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. A REVIEW OF SERVICE RECORDS INDICATES STERIS HAS NOT BEEN CONTACTED TO PERFORM ANY SERVICE ACTIVITIES ON THIS UNIT SINCE MARCH 2006. THE 3080SP SURGICAL TABLE OPERATOR MANUAL STATES (PG. 6-1), "WARNING - PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: SAFE AND RELIABLE OPERATION OF THIS EQUIPMENT REQUIRES REGULARLY SCHEDULED PREVENTIVE MAINTENANCE, IN ADDITION TO THE REGULAR ROUTINE MAINTENANCE. CONTACT STERIS TO SCHEDULE PREVENTIVE MAINTENANCE. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE AND IDENTIFIED THAT THE BOLTS WHICH SECURE THE TILT CYLINDER BRACKET TO THE TABLE WERE NOT FULLY ENGAGED CAUSING THE TABLE TOP TO BECOME UNSTABLE RESULTING IN THE REPORTED EVENT. THE TECHNICIAN REINSTALLED THE BOLTS PROPERLY SECURING THE TILT CYLINDER BRACKET, TESTED THE TABLE, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. WHILE ONSITE, THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON PROPER PREVENTIVE MAINTENANCE PRACTICES AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE 3080SP SURGICAL TABLE BEGAN TO TILT WITHOUT BEING COMMANDED DURING A PATIENT PROCEDURE. THE PATIENT DID NOT FALL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURIES WERE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626110 3080SP SURGICAL TABLE TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1