BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3241316 · Received July 22, 2013

    Report

    Report Number
    2432235-2013-00339
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    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. AFTER EVALUATION OF THE INSTRUMENT, THE FSE DISCOVERED THAT THE POWER SUPPLY HAD FAILED. THE FSE REPLACED THE POWER SUPPLY ASSEMBLY. AFTER REPLACING THE POWER SUPPLY, THE FSE VERIFIED THE INSTRUMENT FUNCTIONALITY. THE CAUSE OF SMOKE BEING EMITTED FROM THE ADVIA CENTAUR INSTRUMENT WAS A MALFUNCTION OF THE POWER SUPPLY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA CENTAUR INSTRUMENT OBSERVED SMOKE EMITTING FROM THE BACK OF THE INSTRUMENT. THE FIRE MARSHALL INSPECTED THE LABORATORY. THERE WERE NO INJURIES OR ILLNESSES SUSTAINED AS A RESULT OF THE SMOKE EMITTED FROM THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341667 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1