BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3233205 · Received July 18, 2013

    Report

    Report Number
    2247117-2013-00075
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THAT THE CAUSE OF THE SMOKE WAS DUE TO A MALFUNCTION IN THE INSTRUMENT POWER SUPPLY. THE FSE REPLACED THE POWER SUPPLY, TWO POWER DISTRIBUTION PRINTED CIRCUIT BOARDS, HOMED THE INSTRUMENT MOTORS, AND RAN CONTROLS. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER DETECTED A SMOKE ODOR COMING FROM THE IMMULITE 2000 INSTRUMENT. THE CUSTOMER TURNED OFF THE INSTRUMENT UNTIL FURTHER INVESTIGATION OCCURRED. THERE WAS NO FIRE AND NO NEED TO EVACUATE THE LABORATORY. THERE ARE NO KNOWN REPORTS OF STAFF INJURY OR PROPERTY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333860 IMMULITE 2000 IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1