BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3974236 · Received August 1, 2014

    Report

    Report Number
    2432235-2014-00462
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DETERMINED THAT THE SMOKE WAS EMITTED FROM THE POWER SUPPLY. THE CSE REPLACED THE POWER SUPPLY AND SUCCESSFULLY RAN QC. THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT WAS DUE TO A MALFUNCTION OF THE POWER SUPPLY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA CENTAUR XP INSTRUMENT OBSERVED SMOKE BEING EMITTED FROM THE INSTRUMENT. THE SMOKE ACTIVATED THE LABORATORY FIRE ALARM. THE LOCAL FIRE DEPARTMENT WAS NOT CONTACTED AND WAS NOT DISPATCHED TO THE CUSTOMER SITE. THE LABORATORY WAS NOT EVACUATED. THE INSTRUMENT WAS POWERED DOWN BY THE CUSTOMER. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449824 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1