BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000A PLATFORM

    MDR report key: 5211617 · Received November 9, 2015

    Report

    Report Number
    2015691-2015-03005
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 20, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K100709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE WERE UNABLE TO CONFIRM THE CUSTOMER'S EXPERIENCE WITHOUT THE RETURN OF THE PRODUCT. IF THE PRODUCT BECOMES AVAILABLE FOR INVESTIGATION, THE EVALUATION FINDINGS WILL BE SUBMITTED. THE INCORRECT LOT NUMBER, MANUFACTURE DATE AND EXPIRATION DATE WERE SUBMITTED INITIALLY. THEY HAVE BEEN UPDATED ON THIS SUBMISSION. THE DEVICE SERVICE HISTORY RECORD REVIEW WAS RE-DONE WITH THE UPDATED LOT NUMBER AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON-CONFORMANCES. THIS NARRATIVE TEXT WAS ENTERED INTO THE INCORRECT SPACE ON A SUPPLEMENTAL REPORT PRIOR TO THIS. THIS IS BEING SUBMITTED IN THE NARRATIVE TEXT BOX AS A CORRECTION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    ONE EV1000A PLATFORM WAS RECEIVED FOR PRODUCT EVALUATION. AN EXAMINATION WAS CONDUCTED ON THE SYSTEM AND IT WAS OBSERVED THAT IT WAS ABLE TO ZERO THE CVP/AP LINE AND ALSO MONITOR THE CO, CI, SV AND SCV02 DURING A THREE DAY PERIOD. IT WAS VERIFIED THAT THE MONITOR WAS UPDATING THE CORRECT PARAMETERS EVERY FIVE MINUTES, AS PER THE PARAMETER SETTINGS, TIME INTERVALS AND AVERAGING. THE BURN IN PROCESS WAS CONDUCTED ON THE UNIT AND ALL PARAMETER READINGS WERE WITHIN PRODUCT SPECIFICATIONS. THE SYSTEM WAS TURNED ON/OFF DURING THE BURN IN PROCESS AND IT WORKED PROPERLY. THE DATABOX WAS TESTED, PER PROCEDURE, BEFORE AND AFTER THE BURN IN PROCESS AND IT PASSED THE COMPLETE AUTOMATED FUNCTIONAL TEST. THERE WAS NO PHYSICAL DAMAGE THAT WAS OBSERVED ON THE DATABOX. THE SYSTEM WILL BE TAKEN OUT OF SERVICE AND DESTROYED AS IT HAS ZERO BOOK VALUE. THE DEVICE SERVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES. THE REPORTED EVENT WAS NOT CONFIRMED BY EVALUATION. THERE IS NO INDICATION OF A MANUFACTURING DEFECT THAT WAS NOTED DURING THE ANALYSIS. IT COULD NOT BE DETERMINED IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EV1000A PLATFORM WAS IN USE AND MONITORING A PATIENT WHEN THERE WERE INACCURATE READINGS THAT DISPLAYED FOR THE CARDIAC INDEX AND CARDIAC OUTPUT. THE CI READING WAS HIGHER THAN THE CO READING. THE PATIENT WAS NOT TREATED WITH THE INACCURATE VALUES AS THE CLINICIAN IMMEDIATELY NOTED THAT THE READINGS WERE INACCURATE. THERE WERE NO ERROR MESSAGES DISPLAYED. THE MONITOR WAS EXCHANGED FOR ANOTHER WHICH RESOLVED THE ISSUE. THERE WERE NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742042 EV1000A PLATFORM EV1000A PLATFORM MONITOR DXG EDWARDS LIFESCIENCES EV1000A EV005028

    Patients

    Seq Age Sex Outcome Treatment
    1