BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1903632 · Received November 16, 2010

    Report

    Report Number
    2432235-2010-00171
    Event Type
    Other
    Date Received
    November 16, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE WHEN THE INCIDENT OCCURRED. AFTER ANALYZING THE INSTRUMENT, THE FSE DETERMINED THAT THE MOUNTING SCREWS THAT HOLD THE RAILS TO THE INSTRUMENT WERE LOOSE. THE FSE INSTALLED DRAWER SLIDES AND GLIDE RAILS ON THE ADVIA CENTAUR SYSTEM. THE INSTRUMENT WAS REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR WAS SLIDING OUT THE WATER/WASTE DRAWER ON THE ADVIA CENTAUR WHEN IT BECAME DETACHED FROM THE INSTRUMENT AND FELL ON HER FOOT. THE EMPLOYEE WENT TO THE HOSPITAL FOR AN EXAMINATION TO DETERMINE IF ANY INJURIES WERE SUSTAINED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE OPERATOR'S INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1