BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE EPS

    MDR report key: 2623167 · Received June 20, 2012

    Report

    Report Number
    9680353-2012-00040
    Date Received
    June 20, 2012
    Date of Event
    May 24, 2012
    Report Date
    June 20, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    PMA / PMN Number
    K102244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE DRIP PAN STRAINER WAS CLOGGED CAUSING WATER TO LEAK ONTO THE FLOOR. THE TECHNICIAN CLEANED THE STRAINER, RAN TEST CYCLES AND RETURNED THE UNIT TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED. THE RELIANCE EPS IS NOT UNDER STERIS SERVICE CONTRACT AND IS SERVICED AND MAINTAINED BY THE USER FACILITY'S CLINICAL ENGINEERING DEPARTMENT. STERIS WILL CONFUCT IN-SERVICE TRAINING ON THE PROPER PREVENTIVE MAINTENANCE OF THE RELIANCE EPS THE WEEK OF (B)(4), 2012.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RELIANCE EPS WAS LEAKING WATER ONTO THE FLOOR AND FLOODED THE ROOM WHERE THE UNIT WAS LOCATED. USER FACILITY PERSONNEL SHUT OFF THE UNIT AND CLEANED UP THE WATER. NO INJURIES, PROCEDURAL DELAYS/CANCELLATIONS OR PROPERTY DAMAGE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE EPS WASHER/DISINFECTOR NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other