BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20" CENTURY SCIENTIFIC VAC

    MDR report key: 2042526 · Received April 6, 2011

    Report

    Report Number
    3005899764-2011-00009
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 10, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS SERVICE TECHNICIAN BELIEVED HE HAD SUFFICIENTLY DRAINED ALL RESIDUAL STEAM FROM THE GENERATOR AND PROCEEDED TO SERVICE THE UNIT. IN THE PROCESS OF REMOVING THE HEATING ELEMENT, RESIDUAL STEAM ESCAPED THE UNIT AND IMPACTED THE TECHNICIAN WHO WAS POSITIONED AT THE OPENING OF THE CHAMBER. ON (B)(6), 2011 STERIS CORPORATE HEALTH AND SAFETY ISSUED A NOTIFICATION TO FIELD MANAGEMENT TO REMIND ALL TECHNICIANS OF THE PROPER INSTRUCTIONS FOR PERFORMING PREVENTATIVE MAINTENANCE ON STEAM STERILIZER GENERATORS AND TO ALWAYS FOLLOW ESTABLISHED PROCEDURES WHEN PERFORMING WORK.

    Description of Event or Problem · 1

    STERIS CONFIRMED THE TECHNICIAN HAS RETURNED TO NORMAL WORK DUTIES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A STERIS SERVICE TECHNICIAN WAS PERFORMING PREVENTATIVE MAINTENANCE ON THE HEATING ELEMENT OF THE STERILIZER'S STEAM GENERATOR WHEN HOT STEAM CAME OUT OF THE GENERATOR'S CHAMBER AND ONTO HIS HANDS, ARMS AND LEG. HE IS BEING TREATED FOR BURNS TO HIS HANDS, ARMS AND LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20" CENTURY SCIENTIFIC VAC STERILIZER, STEAM FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other