BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2794333 · Received October 17, 2012

    Report

    Report Number
    3000251274-2012-00229
    Date Received
    October 17, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 17, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS TECHNICIAN INSPECTED THE SYSTEM 1E AND OBSERVED A STEADY DRIP AT THE PRE A AND B ¾" INCH COPPER PIPE INSTALLED BETWEEN THE PRE A AND B FILTER CAP HOUSINGS. THE TECHNICIAN TIGHTENED THE PIPE AND THE LEAK STOPPED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE STERIS TECHNICIAN OBSERVED WATER ON THE FLOOR OF THE WORKROOM WHERE THE SYSTEM 1E IS LOCATED. NO REPORT OF INJURY, PROPERTY DAMAGE, OR PROCEDURAL DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1