BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE 444 WASHER

    MDR report key: 3083155 · Received April 29, 2013

    Report

    Report Number
    9680353-2013-00047
    Date Received
    April 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 29, 2013
    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 ARRIVED AT THE FACILITY AND FOUND THAT THE LEFT HAND RUNNER THAT THE BASKETS SLIDE ON WHEN LOADED INTO THE MACHINE WAS LOOSE AND MISSING ITS SET SCREWS HOLDING THE GUIDE IN PLACE. WHEN A BRACKET WAS RETURNED FROM THE UNLOAD SIDE, IT PUSHED THE RUNNER UP AGAINST THE LOAD DOOR. THE RUNNER THEN CAUGHT A BRACKET LOCATED ON THE LOAD DOOR, PREVENTING THE DOOR FROM OPENING PROPERLY. THE TECHNICIAN REINSTALLED THE SET SCREWS HOLDING THE GUIDE IN PLACE RAN A TEST CYCLE AND CONFIRMED THE UNIT OPERATIONAL. THE TECHNICIAN INFORMED THE OPERATOR NOT TO ATTEMPT TO MANUALLY OPEN THE LOAD DOOR IN THE EVENT IT DOES NOT OPEN TO SPECIFICATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE LOAD DOOR ON THE RELIANCE WASHER WAS BECOMING STUCK AND WOULD NOT OPEN. THE FACILITY REPORTED AN OPERATOR WAS ATTEMPTING TO OPEN THE LOAD DOOR, WHEN IT BECAME STUCK AT 2 OPEN. THE OPERATOR THEN TRIED TO PUSH THE DOOR UP MANUALLY, AND REPORTED THE DOOR OPENED VERY RAPIDLY, CATCHING HER FINGER BETWEEN THE DOOR AND THE UPPER ACCESS PANEL. THE OPERATOR RECEIVED A SMALL CUT ON HER MIDDLE FINGER, PLACED A BAND-AID ON THE AREA, AND RETURNED TO WORK. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION. THERE ARE NO PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183983 RELIANCE 444 WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1