BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2822046 · Received November 7, 2012

    Report

    Report Number
    2432235-2012-00371
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TOP COVER WAS LOADED WITH AN EMPTY SAMPLE RACK. THE OPERATOR DID NOT REMOVE THE SAMPLE RACK BEFORE OPENING THE COVER. A SIEMENS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE. THE FSE TESTED THE COVER AND DID NOT FIND ANY ISSUES WITH THE COVER THAT COULD PREVENT IT FROM STAYING OPEN ONCE OPENED. THE FSE TESTED THE COVER AND STRUT WITH AND WITHOUT SAMPLE RACKS. WITH SAMPLE RACKS THE COVER MUST BE LIFTED TO WITHIN 3 INCHES FROM THE TOP (95% FULLY OPEN) FOR IT TO HOLD ITSELF UP. WITH THE SAMPLE RACKS REMOVED THE COVER WILL HOLD ITSELF WHEN LIFTED ABOUT 10 INCHES ABOVE THE CLOSED POSITION (ABOUT 30% FULLY OPEN). THE FSE DETERMINED THAT THE STRUT DID NOT APPEAR TO BE WORN OR COMPROMISED BUT HE PROACTIVELY REPLACED IT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE HOOD OF AN ADVIA CENTAUR XP FELL ON THE HEAD OF THE OPERATOR WHILE PERFORMING SOME TROUBLESHOOTING. THE OPERATOR COMPLETED THE SHIFT, VISITED THE ER AFTER THE SHIFT AND TOOK ONE DAY OFF. THERE ARE NO KNOWN REPORTS OF INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1