BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE 777 WASHER

    MDR report key: 2141617 · Received June 27, 2011

    Report

    Report Number
    9680353-2011-00017
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE WASHER AND FOUND THE INDEXING MECHANISM WAS NOT WORKING PROPERLY DUE TO A BROKEN SPRING AND WORN INDEXING GUIDES; THIS RESULTED IN THE BASKET SHIFTING ON THE CONVEYOR AND BECOMING STUCK. THE TECHNICIAN REPLACED THE SPRING AND GUIDES AND PLACED THE UNIT BACK INTO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE EQUIPMENT. THE UNIT IS UNDER STERIS SERVICE CONTRACT AND WAS LAST SERVICED ON (B)(4) 2011. THE STERIS TECHNICIAN CONFIRMED DURING THIS VISIT THE WASHER INDEXING MECHANISM WAS OPERATING PROPERLY; NO ISSUES WERE NOTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN AN OPERATOR OPENED THE SERVICE ACCESS DOOR AND ATTEMPTED TO REMOVE A JAMMED BASKET AFTER THE WASHER ALARMED, THE BASKET POPPED UP AND HIT THE OPERATOR'S HAND. THE OPERATOR OBTAINED A BRUISE AND WENT TO EMPLOYEE HEALTH; THE USER FACILITY WOULD NOT PROVIDE ADDITIONAL INJURY OR TREATMENT INFORMATION. THE USER FACILITY REPORTED THE OPERATOR IS FINE AND HAS NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE 777 WASHER WASHER LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1