BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE 120 CART WASHER

    MDR report key: 3897185 · Received June 26, 2014

    Report

    Report Number
    9680353-2014-00041
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    FLH
    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 INSPECTED THE CART WASHER AND FOUND THE HOT WATER BOOSTER TANK CONTROL TEMPERATURE REQUIRED REPLACEMENT. THE TECHNICIAN REPAIRED THE WASHER, RAN A TEST CYCLE AND CONFIRMED IT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER AND STEAM WERE LEAKING FROM THE RELIANCE 120 CART WASHER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373437 RELIANCE 120 CART WASHER WASHER FLH STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1