BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000 CLINICAL PLATFORM

    MDR report key: 3002862 · Received March 13, 2013

    Report

    Report Number
    2015691-2013-19535
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K110597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED EV1000 WAS UNABLE TO DETECT ANY FAILURE OF THE DEVICE TO FUNCTION AS INTENDED. THE EV1000 WAS TESTED USING A PLUM SIMULATOR. THE DEVICE APPROPRIATELY ZEROED CVP/AP AND MONITORED CO, SVI, AND SCVO2 FOR 24 HOURS. DURING THE 24 HOURS BURN-IN TESTING, RESULTS WERE COLLECTED AND CONFIRMED TO BE WITHIN EXPECTED RANGE. "BT/IT RANGE WAS ALSO TESTED AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS AND THE DEVICE PASSED THE EXTERNAL CVP TEST." NO OTHER DEFECTS OR DAMAGE WAS OBSERVED OR NOTED ON THE DATABOX OR PC PANEL DURING THE VISUAL INSPECTION. THE COMPLAINT COULD NOT BE CONFIRMED DURING THE EVALUATION; THE FAILURE COULD NOT BE REPLICATED AND THE NO DEFICIENCIES WERE NOTED ON THE UNIT." IT COULD NOT BE DETERMINED IF SOME CLINICAL FACTOR MAY HAVE CONTRIBUTED TO THE EVENT REPORTED." NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CVP ON THE EV1000 DID NOT MATCH THE BEDSIDE CVP BY 8-10 POINTS. THE EV1000 UNIT WAS CHANGED OUT AND THE CVP ON EV1000 MATCHED THE BEDSIDE. ALL CABLES USED WERE KNOWN WORKING CABLES. THE CVP WAS ZEROED THE EXACTLY THE SAME ON BOTH EV1000 UNITS. NO OTHER FAULT MESSAGES WERE SEEN. NO OTHER PROBLEMS EXPERIENCED WITH DEFECTIVE EV1000 ASIDE FROM THE CVP NOT COINCIDING WITH BEDSIDE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105959 EV1000 CLINICAL PLATFORM COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES EV1000A TBD

    Patients

    Seq Age Sex Outcome Treatment
    1