BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR

    MDR report key: 4093399 · Received September 16, 2014

    Report

    Report Number
    9680353-2014-00073
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE WASHER AND FOUND MULTIPLE LEAKS ORIGINATING FROM A FLEXIBLE HOSE AND BALL VALVE LOCATED UNDERNEATH THE WASHER. THE TECHNICIAN REPLACED THE HOSE AND BALL VALVE, PERFORMED A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION.THE WASHER WAS INSTALLED IN DECEMBER 2013 AND IS UNDER STERIS WARRANTY. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WATER WAS LEAKING FROM THE BOTTOM OF THEIR RELIANCE VISION SINGLE CHAMBER WASHER. THE WATER WAS REPORTED TO HAVE LEAKED INTO THE OPERATORS' WORKING AREA. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570972 RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1