BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 444 WASHER

    MDR report key: 2072882 · Received April 29, 2011

    Report

    Report Number
    9680353-2011-00010
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 29, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE WASHER AND FOUND ONE SCREW WAS MISSING FROM THE CONTROL ASSEMBLY AS IT HAD COME LOOSE AND HAD FALLEN ONTO NEARBY FLOORING. THE TECHNICIAN RE-INSTALLED THE SCREW TO SECURE THE CONTROL ASSEMBLY IN PLACE AND RETURNED UNIT TO SERVICE. THE TECHNICIAN COULD NOT DUPLICATE THE DOOR OBSTRUCTION ALARM NOTED BY THE OPERATOR. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS EQUIPMENT. THE OPERATOR WAS ATTEMPTING TO CLEAR THE WASHER ALARM BY PLACING THE UNIT IN STANDBY MODE HOWEVER THE OPERATOR MANUAL STATES: "DOOR OBSTRUCTION - PRESS ALARM REPLY TOUCH PAD TO SILENCE BUZZER. ONCE THE DOOR IS OPEN, REMOVE OBSTRUCTION AT BOTTOM OF WASH CHAMBER DOOR." THE USE OF THE STANDBY FUNCTION IS REQUIRED WHEN THE UNIT NEEDS TO BE SHUT DOWN AFTER THE LAST CYCLE OF THE DAY OR WHEN THE WASHER IS NOT IN USE FOR AN EXTENDED AMOUNT OF TIME; THIS FUNCTION IS NOT INTENDED TO RESOLVE WASHER ALARMS. STERIS COMPLETED IN-SERVICE TRAINING ON (B)(4) 2011 REGARDING THE PROPER USE AND OPERATION OF THE EQUIPMENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN AN OPERATOR OPENED THE RIGHT SIDE PANEL TO ACCESS THE CONTROL ASSEMBLY AND RESOLVE A WASHER ALARM, THE ASSEMBLY CAME DOWN AND HIT HER ON THE FOREHEAD. SHE RECEIVED A LACERATION ON HER HEAD AND WENT TO THE FACILITY EMERGENCY ROOM WHERE SHE RECEIVED STITCHES. THE OPERATOR RETURNED TO WORK THE FOLLOWING DAY AND THE USER FACILITY REPORTS SHE IS FINE WITH NO SUSTAINING INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other