BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE 777 WASHER

    MDR report key: 3884612 · Received June 19, 2014

    Report

    Report Number
    9680353-2014-00040
    Date Received
    June 19, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 19, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT, RAN A TEST CYCLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. NO LEAKS WERE NOTED AND THE WASHER WAS RETURNED TO SERVICE. A FEW DAYS FOLLOWING THE EVENT, THE USER FACILITY REPORTED THAT WATER WAS LEAKING. THE TECHNICIAN INSPECTED THE UNIT AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. NO LEAKS WERE NOTED AND THE WASHER WAS RETURNED TO SERVICE. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    FOLLOWING THE REPORTED EVENT THE USER FACILITY REPORTED WATER WAS LEAKING FROM THEIR WASHER. AN EMPLOYEE SLIPPED AND FELL IN THE WATER. THE EMPLOYEE PUT ICE ON HER KNEES AND MISSED TIME FROM WORK. THE USER FACILITY REPORTED THE EMPLOYEE IS BACK TO WORK AND IS FINE. STERIS SERVICE TECHNICIANS RETURNED TO THE USER FACILITY AND FOUND NO ISSUES WITH THE WASHER OR OTHER EQUIPMENT IN THE ROOM. THE TECHNICIANS DRAINED ALL THE WASHERS AT THE SAME TIME AND FOUND THAT THE DRAIN UNDER THE WASHER SUBJECT OF THE REPORTED EVENT WAS BACKING UP CAUSING WATER TO LEAK ONTO THE FLOOR; THE DRAIN REQUIRED CLEANING. THE USER FACILITY IS RESPONSIBLE FOR DRAIN MAINTENANCE AND IS IN THE PROCESS OF TAKING APPROPRIATE ACTIONS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR RELIANCE 777 WASHER. AN EMPLOYEE SLIPPED AND FELL IN THE WATER. THE EMPLOYEE SUSTAINED BRUISES. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED. THE EMPLOYEE IS FINE AND MISSED NO TIME FROM WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361026 RELIANCE 777 WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other