BEUDAMED
    FDA Adverse Event Summary report: N

    20'" CENTURY STERILIZER

    MDR report key: 2781302 · Received October 10, 2012

    Report

    Report Number
    3005899764-2012-00076
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT WATER WAS LEAKING FROM THE BOTTOM OF THE STEAM GENERATOR'S SIGHT GLASS DUE TO MISALIGNMENT OF THE SITE GLASS IN THE HOUSING. THE TECHNICIAN REPLACED THE SIGHT GLASS AND SEALS, RAN SEVERAL TEST CYCLES AND FOUND THE UNIT TO BE OPERATIONAL; NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THE BOTTOM OF THE STERILIZER'S STEAM GENERATOR SIGHT GLASS ONTO THE FLOOR IN THE ROOM WHERE THE UNIT IS LOCATED. NO INJURIES, PROCEDURAL DELAYS/CANCELLATIONS OR PROPERTY DAMAGE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20'" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1