BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STREAMLAB ANALYTICAL WORKCELL

    MDR report key: 1241541 · Received November 21, 2008

    Report

    Report Number
    1226181-2008-00118
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 12, 2008
    Manufacturer
    INPECO S.P.A.
    Product Code
    JJY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REPRESENTATIVE (FSE) WAS DISPATCHED TO THE ACCOUNT. ANALYSIS OF THE INSTRUMENT INDICATE THAT THE CAUSE FOR THE STREAMLAB BELT NOT MOVING WAS WORN MOTOR BRUSHES. THE FSE CORRECTED THE MALFUNCTION. THE TECHNICAL SOLUTION CENTER REPRESENTATIVES WERE INSTRUCTED TO NOT TELL OPERATORS TO PUT THEIR HANDS ON OR NEAR THE BELT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE BELT BENEATH THE TRACK ON A STREAMLAB WAS NOT MOVING. A TECHNICAL SOLUTIONS CENTER REPRESENTATIVE INSTRUCTED THE OPERATOR TO ATTEMPT TO MANUALLY MOVE THE BELT. THE BELT STARTED TO MOVE AND THE OPERATOR'S LEFT HAND WAS CAUGHT BETWEEN THE BELT AND THE PULLEY. THE HAND WAS BADLY BRUISED WITH SLIGHTLY BROKEN SKIN. THE OPERATOR WAS NOT WEARING GLOVES. THE INJURY WAS CLEANED, ANTIBIOTIC OINTMENT WAS APPLIED AND THE INJURY WAS BANDAGED. THE OPERATOR ALSO RECEIVED A TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STREAMLAB ANALYTICAL WORKCELL AUTOMATION SYSTEM JJY INPECO S.P.A. WCC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR