BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 2347153 · Received November 23, 2011

    Report

    Report Number
    2432235-2011-00179
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    November 5, 2011
    Report Date
    November 8, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. TSE (TECHNICAL SERVICE ENGINEER) VISITED THE CUSTOMER SITE AND INSPECTED THE CONDITION OF THE GAS STRUTS SUPPORTING THE LID OF THE ANALYZER. THE TSE FOUND NO EVIDENCE OF MALFUNCTION. THE LABORATORY HAS EXPERIENCED NO FURTHER PROBLEMS WITH THE LID FALLING DOWN SINCE THE EVENT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA 2400 ANALYZER WAS PERFORMING ROUTINE SYSTEM MAINTENANCE, WHEN THE LID OF THE ANALYZER FELL DOWN AND HIT HER ON THE HEAD. THE OPERATOR DID NOT SEEK ANY MEDICAL ATTENTION. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ANALYZER LID FALLING DOWN AND HITTING THE OPERATOR ON THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2400 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1