BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLAB ANALYTICAL WORKCELL

    MDR report key: 3811798 · Received May 15, 2014

    Report

    Report Number
    1226181-2014-00268
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 19, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE DEVICE, THE CSE DETERMINED THAT THE CAUSE OF THE SMOKE EMITTED WAS A COMPRESSOR BURNT OUT DUE TO A LEAK IN THE SYSTEM. THE CSE REPLACED AND RECHARGED THE COMPRESSOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEEING SMOKE COMING FROM THE STREAMLAB CENTRIFUGE MODULE. THE CUSTOMER POWERED OFF THE DEVICE. NO ONE WAS INJURED OR TREATED FOR SMOKE INHALATION. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290132 STREAMLAB ANALYTICAL WORKCELL STREAMLAB ANALYTICAL WORKCELL LXG SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB ANALYTICAL WORKCELL

    Patients

    Seq Age Sex Outcome Treatment
    1