BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3181298 · Received June 21, 2013

    Report

    Report Number
    2432235-2013-00281
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THE CAUSE OF THE SMOKE WAS DUE TO THE INSTRUMENT POWER SUPPLY. THE FSE REPLACED THE POWER SUPPLY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    SMOKE EMISSION WAS DETECTED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INSTRUMENT WAS TURNED OFF TO STOP THE SMOKE EMISSION. THERE WAS NO REPORT OF STAFF INJURY, DAMAGE OF PROPERTY AND NO IMPACT TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282910 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1