BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3854994 · Received June 9, 2014

    Report

    Report Number
    2432235-2014-00356
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CAUSE OF THE SMOKE WAS DUE TO A MALFUNCTION OF THE INSTRUMENT POWER SUPPLY. THE CSE REPLACED THE POWER SUPPLY. THE CUSTOMER SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    SMOKE EMISSION WAS DETECTED FROM THE RIGHT SIDE OF AN ADVIA CENTAUR INSTRUMENT. THE INSTRUMENT WAS TURNED OFF TO STOP THE SMOKE EMISSION. THERE WAS NO REPORT OF INJURY TO STAFF, DAMAGE TO PROPERTY OR IMPACT TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335438 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1