BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE EPS

    MDR report key: 2634977 · Received June 29, 2012

    Report

    Report Number
    9680353-2012-00043
    Date Received
    June 29, 2012
    Date of Event
    June 7, 2012
    Report Date
    June 28, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    PMA / PMN Number
    K102244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS SERVICE TECHNICIAN THE UNIT AND FOUND THAT THE WATER LEAK WAS DUE TO IMPROPER CHANGING OF THE BACTERIAL FILTER. THE TECHNICIAN ASSISTED THE USER FACILITY PERSONNEL WITH INSTALLING A NEW BACTERIAL FILTER; THE UNIT WAS FOUND TO BE OPERATING PROPERLY. THE BACTERIAL FILTER IS TO BE CHANGED APPROXIMATELY EVERY 90 DAYS BY USER FACILITY PERSONNEL AS STATED IN THE OPERATOR MANUAL (PP.6-15). THE RELIANCE EPS IS UNDER WARRANTY AND WAS LAST SERVICED ON (B)(6) 2012.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THE RELIANCE EPS. 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