BEUDAMED
    FDA Adverse Event Summary report: N

    48" CENTURY STERILIZER

    MDR report key: 6175252 · Received December 15, 2016

    Report

    Report Number
    3005899764-2016-00087
    Date Received
    December 15, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 14, 2016
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER. THE TECHNICIAN INSPECTED THE STERILIZER AND FOUND THAT THE PRESSURE REDUCING VALVE (PRV) WAS NOT OPERATING PROPERLY. WHEN THE STEAM EMITTED FROM THE STERILIZER, THE STEAM BLEW ONTO THE BACK OF THE CONTROL BOX SUBSEQUENTLY CAUSING THE STERILIZER TO ALARM AN RTC FAILURE AS REPORTED BY USER FACILITY PERSONNEL. THE TECHNICIAN REBUILT THE PRV, RAN A TEST CYCLE AND CONFIRMED THE STERILIZER TO BE OPERATING PROPERLY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR STERILIZER WAS LEAKING STEAM. NO REPORT OF INJURY. NO PROCEDURE DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826115 48" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1