BEUDAMED
    FDA Adverse Event Summary report: N

    EAGLE EO MONITOR

    MDR report key: 2509965 · Received March 29, 2012

    Report

    Report Number
    3005899764-2012-00020
    Date Received
    March 29, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 29, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLF
    PMA / PMN Number
    K931872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS TECHNICIAN INSPECTED THE EO MONITOR AND FOUND THAT PORT A WAS GIVING FALSE ALARMS. THE TECHNICIAN REPLACED A FAULTY BATTERY AND CPU BOARD CONTROLLING PORT A, RE-CALIBRATED THE EO MONITOR AND RAN A FULL SAMPLING CYCLE ON ALL PORTS WHICH DETECTED NO EO. IT IS CONCLUDED THAT THE ALARMS ORIGINATING FROM PORT A OF THE EO MONITOR WERE FALSE AND NO RELEASE OF EO OCCURRED. THE FALSE ALARMS WERE CAUSED BY A FAULTY BATTERY AND THE CPU BOARD CONTROLLING PORT A OF THE EO MONITOR; BOTH WERE REPLACED. THE EO STERILIZER AND EO MONITOR WERE TESTED SUCCESSFULLY AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE EO MONITOR ATTACHED TO THE EO STERILIZER WAS ISSUING INTERMITTENT EO ALARMS. AFTER THE STERIS TECHNICIAN PERFORMED MAINTENANCE ON THE EO DISPOSER ON (B)(6) 2012, THE ALARM ON THE EO MONITOR WENT OFF. WHEN THIS OCCURRED, THE STERILE PROCESSING DEPARTMENT (SPD) ) WAS EVACUATED PER ESTABLISHED FACILITY PROCEDURES AND THE FIRE DEPARTMENT CALLED. A (B)(6) TEAM RESPONDED AND DETECTED NO EO GAS, AFTER WHICH THE SPD DEPARTMENT STAFF RETURNED TO WORK. NO INJURIES WERE REPORTED, NO MEDICAL TREATMENT WAS SOUGHT AND NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EO MONITOR STERILIZER MONITOR FLF STERIS MEXICO, S. DE R.L. DE C.V. MP844903

    Patients

    Seq Age Sex Outcome Treatment
    1 Other