BEUDAMED
    FDA Adverse Event Summary report: N

    EVOLUTION MEDIUM STEAM STERILIZER

    MDR report key: 3023834 · Received March 27, 2013

    Report

    Report Number
    3005899764-2013-00027
    Date Received
    March 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER, AND FOUND THE VACUUM PUMP REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE VACUUM PUMP, TESTED THE STERILIZER, FOUND IT TO BE OPERATIONAL AND RETURNED IT TO SERVICE. (B)(4). STERIS ENGINEERING STATES THIS IS AN ISOLATED EVENT. STERIS ENGINEERING RECOMMENDED THE STERIS SERVICE TECHNICIAN REDUCE THE INCOMING WATER PRESSURE, WHICH WAS NOTED TO BE RATED CLOSE TO THE MAXIMUM SPECIFICATION DURING PREVIOUS MAINTENANCE ACTIVITIES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE STERILIZER RELEASED A LARGE QUANTITY OF STEAM UPON OPENING THE DOOR OF THE UNIT, AND SET OFF THE FIRE ALARM. THE FIRE DEPARTMENT WAS DISPATCHED. NO EVACUATION OF THE FACILITY OCCURRED. NO INJURIES WERE REPORTED. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED. NO PROPERTY DAMAGE WAS NOTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125545 EVOLUTION MEDIUM STEAM STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1