BEUDAMED
    FDA Adverse Event Summary report: N

    60" CENTURY STERILIZER

    MDR report key: 3601633 · Received January 31, 2014

    Report

    Report Number
    3005899764-2014-00007
    Date Received
    January 31, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 31, 2014
    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 INSPECTED THE UNIT AND FOUND THAT THE INTERNAL BELLOWS OF THE PRESSURE REGULATORY VALVE (PRV) WERE WORN WHICH CAUSED IT TO RUPTURE AND ALLOW THE STEAM TO ESCAPE. THE TECHNICIAN REBUILT THE PRV, ENERGIZED THE STEAM VALVE, BROUGHT THE UNIT UP TO PRESSURE, RAN A DART WARM-UP TEST AND CONFIRMED THE UNIT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT STEAM WAS LEAKING FROM THEIR STERILIZER SUBSEQUENTLY SETTING OFF THE FIRE ALARM AND DISPATCHING THE FIRE DEPARTMENT. THE HALLWAY IN WHICH THE FIRE ALARM IS LOCATED WAS EVACUATED. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67039 60" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1