BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE EPS

    MDR report key: 2592513 · Received May 30, 2012

    Report

    Report Number
    9680353-2012-00035
    Date Received
    May 30, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 30, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    PMA / PMN Number
    K102244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE UNIT AND FOUND THE HOSE CLAMP ON THE UNIT'S WATER SUPPLY LINE HAD LOOSENED CAUSING THE HOSE TO COME OFF THE FITTING AND WATER TO LEAK. THE TECHNICIAN REPLACED THE HOSE AND CLAMP, TIGHTENED ALL CONNECTIONS AND PLACED THE UNIT BACK INTO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS EQUIPMENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE HOSE ON THE WATER LINE OF THE RELIANCE ENDOSCOPE PROCESSING SYSTEM DISCONNECTED AND FLOODED THE ROOM WHERE IT WAS LOCATED. NO INJURIES, PROCEDURAL DELAYS OR CANCELLATIONS 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