BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 5526395 · Received March 25, 2016

    Report

    Report Number
    2432235-2016-00156
    Event Type
    Malfunction
    Date Received
    March 25, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 2, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00156 WAS FILED ON MARCH 25, 2016. CORRECTED INFORMATION (4/13/2016): IN INITIAL MDR 2432235-2016-00156, THE PRODUCT CODE PROVIDED WAS MOI. THE CORRECT CODE IS JJE AND THE INFORMATION HAS BEEN CORRECTED.

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT, THE CSE REPLACED A FAILED POWER SUPPLY WITH A NEW ONE. THE CSE PERFORMED THE DAILY CLEANING PROCEDURES, AND THE CUSTOMER RAN QUALITY CONTROLS WHICH RESULTED WITHIN RANGE. UPON FOLLOW UP, THE SIEMENS CUSTOMER CARE CENTER CONFIRMED THAT THE HEALTH OF THE OPERATORS WAS WELL AND ONLY ONE EMPLOYEE NEEDED AN INHALER DUE TO BEING ASTHMATIC. THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT WAS A POWER SUPPLY MALFUNCTION. 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 SMELLED BURNING ELECTRICAL COMPONENTS AND OBSERVED SMOKE BEING EMITTED FROM THE BACK OF THE INSTRUMENT. ONE EMPLOYEE NEEDED OXYGEN AFTER SMOKE INHALATION AS THE EMPLOYEE IS ASTHMATIC. 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
    182963 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1