BEUDAMED
    FDA Adverse Event Summary report: N

    16" EAGLE STEAM STERILIZER

    MDR report key: 3952887 · Received July 23, 2014

    Report

    Report Number
    3005899764-2014-00060
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE STERILIZER AND CONFIRMED THAT THE CAUSE OF THE LEAK WAS DUE TO THE CHANGE IN FACILITY'S PSI LEVEL. ACCORDING TO THE TECHNICIAN, THE FACILITY CHANGED THE STEAM SUPPLY PRESSURE TO GO ABOVE THE REQUIRED PSI MEASUREMENT. THE FACILITY HAD THE STEAM PRESSURE SET AT 85-90 PSI WHEN SPECIFICATIONS FOR THE STERILIZER STATE THE PRESSURE SHOULD BE NO MORE THAN 80 PSI. THE TECHNICIAN REPAIRED THE UNIT BY REBUILDING ALL THE VALVES INCLUDING THE PRESSURE REGULATOR VALVE. HE ALSO HAD THE FACILITY LOWER THEIR STEAM PRESSURE TO 75 PSI. AFTER THE NECESSARY REPAIRS THE UNIT WAS RESUMED TO OPERATIONS ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    NO INJURIES WERE REPORTED HOWEVER, A PROCEDURAL DELAY WAS REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A STEAM LEAK FROM THEIR 16" EAGLE STEAM STERILIZER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430229 16" EAGLE STEAM STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1