BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16" CENTURY STERILIZER

    MDR report key: 7743521 · Received August 2, 2018

    Report

    Report Number
    3005899764-2018-00078
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    July 6, 2018
    Report Date
    August 2, 2018
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE 16" CENTURY STERILIZER. THE TECHNICIAN INSPECTED THE UNIT AND FOUND THE ROOT CAUSE OF THE EVENT TO BE ATTRIBUTED TO THE PRESSURE REGULATOR VALVE (PRV). THE PRV WAS SET TOO HIGH WHICH CAUSED THE SAFETY VALVE TO BREAK, CREATING THE REPORTED STEAM LEAK. THE TECHNICIAN ADJUSTED THE PRV TO THE PROPER SETTING AND REPLACED THE SAFETY VALVE, RAN A TEST CYCLE AND FOUND THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATION. THE 16" CENTURY STERILIZER WAS INSTALLED IN 2009 AND IS UNDER STERIS SERVICE AGREEMENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR 16" CENTURY STERILIZER WAS LEAKING STEAM. NO INJURY, PROCEDURE DELAY, OR CANCELLATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586594 16" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1