BEUDAMED
    FDA Adverse Event Summary report: N

    26" EVOLUTION STERILIZER

    MDR report key: 3408369 · Received October 14, 2013

    Report

    Report Number
    3005899764-2013-00106
    Date Received
    October 14, 2013
    Date of Event
    September 19, 2013
    Report Date
    October 14, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE BONNET CRACKED INSIDE THE PRV. THE TECHNICIAN REBUILT THE PRV, TESTED THE UNIT AND CONFIRMED IT 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 BACK OF THEIR STERILIZER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526102 26" EVOLUTION STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1