BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE 444 WASHER/DISINFECTOR

    MDR report key: 2880264 · Received December 19, 2012

    Report

    Report Number
    9680353-2012-00125
    Date Received
    December 19, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THE HOSE DRAIN TO BE CRACKED AND LEAKING WATER. THE TECHNICIAN REPLACED THE HOSE, REBUILT THE DRAIN VALVE AND MADE ADJUSTMENTS TO CLAMPS. THE TECHNICIAN RAN A TEST CYCLE AND CONFIRMED THE UNIT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM UNDERNEATH THE RELIANCE 444 WASHER. NO INJURIES OR PROCEDURAL DELAY/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE 444 WASHER/DISINFECTOR WASHER/DISINFECTOR MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1