BEUDAMED
    FDA Adverse Event Summary report: N

    60" EVOLUTION MEDIUM VAC STERILIZER

    MDR report key: 4103128 · Received September 19, 2014

    Report

    Report Number
    3005899764-2014-00090
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 19, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN INSPECTED AND IDENTIFIED A CRACKED BRASS FITTING ON THE WATER PRESSURE SWITCH LINE. THE STERIS FIELD SERVICE TECHNICIAN THEN REPLACED A WORN DRAIN FUNNEL. THE CRACKED FITTING ALLOWED WATER TO LEAK FROM THE STERILIZER. THE STERIS FIELD SERVICE TECHNICIAN REPAIRED THE BRASS FITTING AND TESTED THE UNIT TO ENSURE IT WAS OPERATIONAL ACCORDING TO SPECIFICATIONS. THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WATER WAS LEAKING FROM THEIR STEAM STERILIZER. NO REPORT OF INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581858 60" EVOLUTION MEDIUM VAC STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1