BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE 120 CART WASHER

    MDR report key: 2963924 · Received February 15, 2013

    Report

    Report Number
    9680353-2013-00014
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE AND FOUND THAT THE WATER LEVEL SENSORS WERE NOT WORKING PROPERLY. THE SERVICE TECHNICIAN CLEANED AND REBUILT THE WATER FILL (SOLENOID) VALVE AND SUMP FLOAT (CHAMBER WATER LEVEL CONTROL). A TEST CYCLE WAS RUN AND THE UNIT WAS OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR RELIANCE CART WASHER WAS LEAKING WATER FROM THE BOTTOM OUT ONTO THE FLOOR. NO PROCEDURAL DELAYS OR CANCELLATIONS REPORTED. NO INJURY TO HOSPITAL STAFF OR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67437 RELIANCE 120 CART WASHER WASHER LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1