BEUDAMED
    FDA Adverse Event Summary report: N

    60" EVOLUTION MEDIUM STERILIZER

    MDR report key: 3118949 · Received May 19, 2013

    Report

    Report Number
    3005899764-2013-00043
    Date Received
    May 19, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE UNIT AND FOUND THE STEAM PRESSURE REGULATOR VALVE (PRV) BROKEN. THE STEAM PRV IS COMPOSED OF TWO PARTS: THE STEM ASSEMBLY AND SYLPHON. THE STEM ASSEMBLY CONTROLS THE AMOUNT OF STEAM TO THE UNIT, AND IS CLOSED ONCE THE CORRECT AMOUNT OF PRESSURE IS MET. THE TECHNICIAN FOUND THE STEM ASSEMBLY AND SYLPHON BOTH BROKEN INTO TWO PARTS. THE TECHNICIAN INSTALLED A NEW STEAM PRV INTO THE UNIT AND CONFIRMED THE UNIT TO BE OPERATIONAL. THE UNIT WAS INSTALLED IN (B)(6) 2010 AND IS CURRENTLY UNDER A STERIS SERVICE CONTRACT. THE LAST PREVENTATIVE MAINTENANCE FOR THE UNIT WAS COMPLETED ON (B)(6) 2013. DURING THIS TIME, THE TECHNICIAN REPLACED THE STEAM PRV, AS INSTRUCTED IN THE PREVENTATIVE MAINTENANCE CHECK LIST, AND CONFIRMED THE UNIT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR UNIT WAS LEAKING STEAM. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220617 60" EVOLUTION MEDIUM STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1