BEUDAMED
    FDA Adverse Event Summary report: N

    EAGLE EO MONITOR

    MDR report key: 3211373 · Received July 8, 2013

    Report

    Report Number
    3005899764-2013-00067
    Date Received
    July 8, 2013
    Date of Event
    June 9, 2013
    Report Date
    July 8, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY TO INSPECT THE UNIT. THE TECHNICIAN CONFIRMED THAT NO ETO STERILIZERS WERE RUNNING ON THE DAY OF THE REPORTED EVENT. THE MONITOR WAS FOUND TO BE OPERATING TO SPECIFICATION. EMERGENCY SERVICES WERE CONTACTED BY THE USER FACILITY. THE EO ALARM TURNED OFF BEFORE THEY ARRIVED. THE MONITOR ALARMED FOR ONE FULL CYCLE ONLY. THE TECHNICIAN CONFIRMED THE ALARM INITIATED BY A NON-EO ODOR AS THE MONITOR IS LOCATED IN AREA WITH MULTIPLE DEVICES AND FREQUENT TRAFFIC.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR EAGLE EO MONITOR WAS ALARMING ¿HIGH LEAK RATE OF 9.12¿. THE SURGICAL DEPARTMENT WAS EVACUATED AND EMERGENCY SERVICES WERE CONTACTED. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310854 EAGLE EO MONITOR STERILIZER MONITOR FLF STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other