BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 4121781 · Received September 26, 2014

    Report

    Report Number
    2432235-2014-00566
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, THE CSE ORDERED PARTS AND WILL RETURN TO THE CUSTOMER SITE TO INSTALL THE PARTS. THE CUSTOMER STATED THEY WOULD PLACE A NOTE ON THE LID UNTIL THE REPAIR WAS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THAT THE COVER OF AN ADVIA CENTAUR INSTRUMENT HAD FALLEN WHILE AN OPERATOR HAD IT RAISED TO PERFORM TROUBLESHOOTING. THE OPERATOR WAS NOT INJURED WHEN THE LID FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601382 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1