BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

    MDR report key: 1960624 · Received January 13, 2011

    Report

    Report Number
    2015691-2011-14670
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE DID NOT CONFIRM THE CUSTOMER'S REPORTED ISSUE OF 'FALSE READINGS'. MEASUREMENT FUNCTIONS WORKED PROPERLY ACCORDING TO STANDARD TEST PROCEDURES. HOWEVER, A LOOSE CONTACT LOCATED INSIDE THE FUSE HOLDER WAS FOUND, RESULTING IN A FAILURE OF THE MONITOR TO WORK INTERMITTENTLY. THE ROOT CAUSE OF THE LOOSE CONTACT COULD NOT BE DETERMINED. THERE ARE NO INDICATIONS THAT THESE EVENTS ARE RELATED.

    Description of Event or Problem · 1

    THE VIGILEO MONITOR WAS REPORTED AS GIVING FALSE READINGS. NO ADDITIONAL DETAILS WERE PROVIDED REGARDING THE NATURE OF THE 'FALSE' READINGS. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR CARDIAC OUTPUT/OXIMETRY MONITOR DXG EDWARDS LIFESCIENCES MHM1E

    Patients

    Seq Age Sex Outcome Treatment
    1