BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEAM GENERATOR

    MDR report key: 2042524 · Received April 6, 2011

    Report

    Report Number
    3005899764-2011-00010
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 6, 2011
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE GENERATOR AND FOUND THE UNIT WAS OPERATING PROPERLY. THE CAUSE OF THIS EVENT IS OPERATOR ERROR AS THE USER FACILITY REPORTED THE OPERATOR TURNED THE POWER TO THE GENERATOR ON, LEFT THE ROOM AND RETURNED LATER TO OPEN THE DRAIN VALVES TO DRAIN THE UNIT. THE PROPER PROCEDURE IS TO OPEN THE VALVES AND DRAIN THE UNIT WHILE THE POWER IS OFF AND THE UNIT IS COOL. THE EQUIPMENT MAINTENANCE MANUAL STATES CAUTION: "WAIT UNTIL BOILER PRESSURE GAUGE INDICATES "0" PRESSURE AND HAS COOLED TO 140 F BEFORE PERFORMING FLUSH PROCEDURE. POSITION CONTROL POWER SWITCH OFF, OPEN THE BOILER DRAIN VALVE." THE STERIS SERVICE TECHNICIAN PERFORMED AN IN-SERVICE ON (B)(6) 2011 ON THE CORRECT METHOD TO PERFORM THE DRAIN AND FLUSH PROCEDURE ON THE GENERATOR.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN OPERATOR OPENED THE VALVES TO PERFORM THE DRAIN AND FLUSH PROCEDURE FOR A GENERATOR WHEN STEAM AND HOT WATER ESCAPED FROM THE UNIT, CAUSING A BURN ON HER LEG. THE EMPLOYEE RECEIVED MEDICAL TREATMENT FOR A SECOND DEGREE BURN AT THE WORKERS COMPENSATION MEDICAL DEPARTMENT. THE USER FACILITY REPORTED THE EMPLOYEE IS FINE AND HAS NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEAM GENERATOR STEAM GENERATOR - WASHER COMPONENT FLE STERIS MEXICO, S. DE R.L. DE C.V. CH08-861-500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other