BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT /OXIMETERY MONITOR

    MDR report key: 3945150 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01640
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED 24-FEB-2012 AND REVIEW OF THE DEVICE HISTORY RECORD SUPPORTS THAT THERE WERE NO NON-CONFORMANCES NOTED FOR ANY REASON. EXAMINATION OF THE RETURNED MONITOR WAS UNABLE TO REPLICATE THE REPORTED PERFORMANCE OF THE DEVICE. 36 HOURS OF ¿BURN-IN¿ TESTING WAS PERFORMED WITH NO ISSUES NOTED. ADDITIONALLY, FINAL ACCEPTANCES TEST UNIT (FATU) TESTING AND SAFETY TESTING ALSO CORROBORATE THAT THE MONITOR PERFORMS AS EXPECTED. NO PHYSICAL DAMAGE WAS OBSERVED DURING THE VISUAL INSPECTION. IT IS UNKNOWN WHETHER PROCEDURAL PROCESSES OR A SPECIFIC CIRCUMSTANCE PLAYED A ROLE IN THE REPORTED EVENT, AS NO FAULT COULD BE IDENTIFIED AND THE MONITOR FUNCTIONED APPROPRIATELY BEFORE BEING RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT WAS NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP SUBMISSION WILL COMMUNICATE THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW, THE RETURNED PRODUCT EVALUATION RESULT(S), INVESTIGATION, AND CONCLUSION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS SALES INSPECTED THE VIGILEO MONITOR AFTER UPGRADING THE SOFTWARE TO VERSION 4.0 AND THE CARDIAC OUTPUT (CO) FLUCTUATED FROM 1.3 TO 2.6 L/MIN. NO ALERT OR ALARMS WERE REPORTED WITH RESPECT TO THIS EVENT AND NO PATIENT COMPROMISE OCCURRED, AS NO PATIENT WAS INVOLVED. NO ADDITIONAL SYSTEM-RELATED DEVICES WERE IDENTIFIED AS SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423220 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT /OXIMETERY MONITOR COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES MHM1

    Patients

    Seq Age Sex Outcome Treatment
    1