BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3874096 · Received June 16, 2014

    Report

    Report Number
    2432235-2014-00375
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 4, 2014
    Report Date
    December 13, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Removal / Correction Number
    2432235-02/21/14-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE REPLACED THE GAS SPRING ON THE MAIN LID COVER. THE CAUSE OF THE INSTRUMENT COVER FALLING ONTO THE OPERATOR WAS A MALFUNCTION OF THE GAS SPRING. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE OCCURRENCES OF ADVIA CENTAUR XP INSTRUMENT COVERS FALLING DURING MAINTENANCE PROCEDURES. WHEN THE INSTRUMENT COVER IS RAISED, THE COVER IS SUPPORTED BY A GAS SPRING ATTACHED AT THE MIDDLE OF THE COVER. OVER TIME, THE GAS SPRING MAY LOSE ITS EFFECTIVENESS AND FAIL TO SUPPORT THE COVER IN ITS FULL OR PARTIALLY OPEN POSITION. THIS MAY LEAD TO THE COVER FALLING DURING MAINTENANCE PROCEDURES. CUSTOMERS IN THE UNITED STATES WERE SENT URGENT MEDICAL DEVICE CORRECTION (UMDC) 10817522 ENTITLED "ADVIA CENTAUR XP INSTRUMENT COVER GAS SPRING ISSUES" IN FEBRUARY 2014. CUSTOMERS OUTSIDE OF THE UNITED STATES WERE SENT URGENT FIELD SAFETY NOTICE (UFSN) 10817521 ENTITLED "ADVIA CENTAUR XP INSTRUMENT COVER GAS SPRING ISSUES" IN FEBRUARY 2014. THE UMDC/UFSN PROVIDES GUIDANCE TO CUSTOMERS BY EXPLAINING ACTIONS TO AVOID INJURY AND TO CONTACT THEIR SIEMENS TECHNICAL SUPPORT REPRESENTATIVE IF THE COVER CANNOT STAY PARTIALLY RAISED. SIEMENS TECHNICAL SUPPORT REPRESENTATIVES WILL BE ROUTINELY INSPECTING GAS SPRINGS ON REGULAR PREVENTIVE MAINTENANCE CYCLES OR SERVICE VISITS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THAT THE COVER OF AN ADVIA CENTAUR XP INSTRUMENT HAD FALLEN ONTO AN OPERATOR, HITTING THEIR NOSE. THE OPERATOR SUSTAINED ON A SCRATCH ON HER NOSE BUT NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352986 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MOI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1