BEUDAMED
    FDA Adverse Event Summary report: N

    16" CENTURY STERILIZER

    MDR report key: 3081095 · Received April 26, 2013

    Report

    Report Number
    3005899764-2013-00037
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND FOUND THE UNIT TO BE SHUT OFF AND OUT OF USE. THE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE DRAIN VALVE ON THE STEAM GENERATOR WAS NOT CLOSED ALL THE WAY. THE TECHNICIAN REPAIRED THE UNIT BY REPLACING THE BALL VALVE ON THE STEAM GENERATOR DRAIN ALONG WITH REPLACING 2 CHECK VALVES. THE TECHNICIAN FURTHER INSPECTED THE UNIT AS HE WANTED TO VERIFY PROPER OPERATION OF THE S7 WATER VALVE AND CHECK VALVE ON THE WATER MANIFOLD. THE TECHNICIAN REBUILT THE S7 WATER VALVE AS A PRECAUTIONARY MEASURE AND CONFIRMED THE UNIT TO BE OPERATIONAL; NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT STEAM ESCAPED FROM THE STERILIZER SETTING OFF THE FIRE ALARM. THE FIRE DEPARTMENT WAS DISPATCHED AND THE BUILDING WAS EVACUATED. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182985 16" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1