BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLAB® ANALYTICAL WORKCELL

    MDR report key: 7000750 · Received November 3, 2017

    Report

    Report Number
    2517506-2017-00802
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 3, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LGX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THE SMOKE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. SERVICE WAS PERFORMED OVER MULTIPLE VISITS. THE CSE TESTED THE CENTRIFUGE FUNCTIONALITY AND IT WAS PROPER. THE CSE INSPECTED THE CENTRIFUGE MODULE AND HAD ISSUES WITH CENTRIFUGE ROBOT ROTATIONAL. THE CSE REPLACED THE ROTATIONAL AND VERTICAL STEPPER BOARDS. THE CSE INSTALLED STEPPER DRIVER BOARDS. THE CSE REPLACED STEPPER DRIVER BOARDS FOR CENTRIFUGE ROBOTS Y AND Z. THE CSE VERIFIED OPERATION OF CENTRIFUGE ROBOT, WHICH WAS ACCEPTABLE. THE CSE FOUND CONDENSATION INSIDE AIRLINES AND AIR COMPRESSOR RUNNING NONSTOP. THE CSE REPLACED START UP AND UNLOADER VALVES ON AIR COMPRESSOR AND WATER TRAP ON INCOMING AIRLINE. THE CSE TESTED STREAMLAB IN DIAGNOSTICS, WHICH PASSED. THE CSE WATCHED STREAMLAB PROCESS SAMPLES. THE CAUSE OF THE SMOKE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    SMOKE WAS EMITTED FROM A STREAMLAB CORE UNIT CENTRIFUGE. THE CENTRIFUGE WAS POWERED OFF. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE EVENTS DUE THE SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778701 STREAMLAB® ANALYTICAL WORKCELL STREAMLAB® ANALYTICAL WORKCELL LGX SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB® ANALYTICAL WORKCELL

    Patients

    Seq Age Sex Outcome Treatment
    1