BEUDAMED
    FDA Adverse Event Summary report: N

    EQUIPMENT MANAGEMENT SYSTEM

    MDR report key: 1961763 · Received January 14, 2011

    Report

    Report Number
    1043572-2011-00004
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 14, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE EQUIPMENT MANAGEMENT SYSTEM (EMS) AND FOUND NO PROBLEMS WITH THE SYSTEM OUTSIDE OF THE BROKEN BRAKE COVER. THE TECHNICIAN WAS UNABLE TO CHECK THE PRESSURE TO THE SYSTEM AS THE NITROGEN GAS SUPPLY HAD BEEN TURNED OFF TO THE OPERATING ROOM. THE TECHNICIAN REPLACED THE BRAKE COVER AND BRAKE HOSE, AND HAD THE FACILITY TURN ON THE NITROGEN GAS SUPPLY SO THAT THE CORRECT PRESSURE SETTING COULD BE VERIFIED. THE EMS HAS BEEN PLACED BACK INTO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS EQUIPMENT. UPON FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE EMS PRESSURE REGULATORS IN FOUR OTHER OPERATING ROOMS AT THE FACILITY WERE SET TOO HIGH AND THAT ALL OF THE BRAKE COVERS IN THESE OPERATING ROOMS HAD VARYING SIZES OF CRACKS DUE TO THE HIGH PRESSURE SETTINGS. THE TECHNICIAN ADJUSTED THE NITROGEN PRESSURE IN THESE FOUR OPERATING ROOMS AND THE USER FACILITY HAS REPLACED THE CRACKED BRAKE COVERS. THE MAINTENANCE MANUAL STATES ON PP 3-3 THAT AT EACH INSPECTION "1.2 CHECK OVERALL SYSTEM FOR APPEARANCE, VISUAL DAMAGE, MISSING/LOOSE PARTS OR DEFORMATION". AND "2.4 CHECK COVERS FOR SIGNS OF CRACKING/BINDING". ADDITIONALLY, THE MAINTENANCE MANUAL STATES ON PP 6-1 "EVERY YEAR, ENGAGE A PROFESSIONAL TESTING SERVICE TO CHECK ALL PRESSURE HOSES AND CABLES". THE EMS IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY'S BIOMEDICAL DEPARTMENT. STERIS OFFERED TO CONDUCT IN-SERVICE TRAINING REGARDING PROPER PREVENTIVE MAINTENANCE PROCEDURES OF THIS EMS HOWEVER THE USER FACILITY DECLINED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PRIOR TO THE START OF A PATIENT PROCEDURE, HOSPITAL STAFF OBSERVED A CRACK IN THE BRAKE COVER AND PART OF THE BRAKE HOSE BEHIND THE BRAKE COVER OF THE EQUIPMENT MANAGEMENT SYSTEM (EMS). THE STAFF TOOK NO ACTION TO ADDRESS THE CRACKED BRAKE COVER AND AS THE PATIENT WAS BEING PREPARED, THE BRAKE HOSE RUPTURED, CAUSING A LOUD NOISE AND RELEASING NITROGEN INTO THE OPERATING ROOM. NITROGEN IS USED TO FILL THE BLADDER BEHIND THE BRAKE COVER WHICH PREVENTS THE EMS FROM MOVING DURING A PATIENT PROCEDURE. THE PATIENT WAS TRANSFERRED TO ANOTHER OPERATING ROOM WHERE THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITHOUT INCIDENT. NO INJURIES WERE REPORTED TO HOSPITAL STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPMENT MANAGEMENT SYSTEM EQUIPMENT MANAGEMENT SYSTEM FQO STERIS CORPORATION - MONTGOMERY CS DF100

    Patients

    Seq Age Sex Outcome Treatment
    1