BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISION SINGLE CHAMBER WASHER

    MDR report key: 2193357 · Received August 5, 2011

    Report

    Report Number
    9680353-2011-00019
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 5, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE WASHER AND FOUND THE EQUIPMENT TO BE OPERATING PROPERLY; THE DOOR SAFETY SWITCHES WERE OPERATING AS INTENDED. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE WASHER. THE WASHER IS UNDER STERIS WARRANTY AND WAS LAST SERVICED ON (B)(4) 2011 DURING PREVENTATIVE MAINTENANCE. NO ISSUES WERE NOTED AT THIS TIME. THE OPERATOR DID NOT LOAD THE WASHER CORRECTLY AS A HANDLE FROM A BASKET ON THE LOADING CART WAS STICKING OUT. PER OPERATOR MANUAL (4-2), "ENSURE NO ITEMS STICK OUT OR HANG OUT OF RACK. ALWAYS USE A RACK DESIGNED TO HANDLE APPROPRIATE TYPES OF ITEMS TO BE PROCESSED". OPERATOR MANUAL STATES (PP.4-35): "WARNING- IF AN OBSTRUCTION IS PRESENT IN THE CHAMBER DOOR, DO NOT ATTEMPT TO REMOVE THE OBJECT. DOOR AUTOMATICALLY RAISES AND REMAINS OPEN". STERIS OFFERED A REFRESHER IN-SERVICE TRAINING ON THE PROPER PROCEDURE FOR LOADING THE VISION SINGLE CHAMBER WASHER AND IS AWAITING A RESPONSE.

    Additional Manufacturer Narrative · 1

    IN-SERVICE TRAINING IS SCHEDULED FOR (B)(6) 2011 ON THE PROPER PROCEDURE FOR LOADING THE VISION SINGLE CHAMBER WASHER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE EMPLOYEE IS FINE WITH NO SUSTAINING INJURIES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN AN OPERATOR WAS LOADING THE WASHER THE DOOR OBSTRUCTION ALARM OCCURRED. WHILE THE OPERATOR WAS CLEARING THE OBSTRUCTION THE DOOR REPORTEDLY CLOSED ON THE OPERATOR'S HAND. THE OPERATOR RECEIVED SKIN BREAKS, SWELLING AND PAIN TO HER SHOULDER. SHE WAS GIVEN AN IMMOBILIZER BRACE AND RECEIVED X-RAYS ON HER HAND. THE EMPLOYEE HAS RETURNED TO NORMAL WORK DUTIES AND IS CONTINUING TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION SINGLE CHAMBER WASHER WASHER/DISINFECTOR MEC STERIS CANADA CORPORATION 1932982

    Patients

    Seq Age Sex Outcome Treatment
    1 Other