BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE VISION MULTI CHAMBER WASHER

    MDR report key: 2132645 · Received June 17, 2011

    Report

    Report Number
    9680353-2011-00015
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 16, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE WASHER AND FOUND A GEAR WAS BROKEN. THE TECHNICIAN REPLACED THE GEAR 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 BASKET DRIVE AND GEAR COMPONENTS WERE INSPECTED AND WERE OPERATING PROPERLY; NO ISSUES NOTED. STERIS HAS DETERMINED THIS IS AN ISOLATED EVENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AS AN OPERATOR WAS EXITING THE WASHER CHAMBER SHE HIT HER HEAD ON THE SERVICE ACCESS DOOR. THE OPERATOR WENT TO THE EMERGENCY ROOM WHERE NEUROLOGICAL TESTS WERE COMPLETED; THE OPERATOR MISSED TWO DAYS OF WORK DUE TO A CONCUSSION. THE USER FACILITY REPORTED THE OPERATOR HAS RETURNED TO NORMAL WORK DUTIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other