BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000A PLATFORM

    MDR report key: 5004762 · Received August 14, 2015

    Report

    Report Number
    2015691-2015-02060
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 23, 2015
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DXG
    PMA / PMN Number
    K100709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE EV1000 PLATFORM WAS RETURNED TO EDWARDS FOR PRODUCT EVALUATION. THE EVALUATION FOUND THAT AFTER PERFORMING THE EVFTS TEST FOR FOUR HOURS ON THE SYSTEM THAT THE REPORTED ISSUE WAS NOT CONFIRMED. IT WAS REPORTED THAT THERE WAS A TOUCHSCREEN FAILURE ON THE UNIT AND THAT THE MAP ON THE EV1000 MONITOR AND THE MAP ON THE BEDSIDE PATIENT MONITOR DID NOT MATCH. THIS WAS NOT CONFIRMED THROUGH EVALUATION. HOWEVER, IT WAS FOUND THAT THE GENDER CHANGER ON THE UNIT WAS MISSING. THIS COMPONENT WAS REPLACED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE/SERVICE HISTORY RECORD REVIEW WAS COMPLETED AND THERE WAS A NON-CONFORMANCE THAT WAS GENERATED DURING THE MANUFACTURING PROCESS; HOWEVER, IT WAS NOT RELATED TO THE REPORTED COMPLAINT ISSUE. THE REPORTED EVENT WAS NOT CONFIRMED BY EVALUATION. IT COULD NOT BE DETERMINED IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE MONITORING A PATIENT, THE ARTERIAL PRESSURE VALUES THAT WERE DISPLAYED ON THE EDWARDS EV1000 MONITOR DID NOT MATCH WITH THE ARTERIAL PRESSURE VALUES ON THE PATIENT BEDSIDE MONITOR. HOWEVER, THE ARTERIAL WAVEFORMS ON BOTH UNITS DID MATCH. IT IS UNKNOWN WHETHER THERE WERE ANY ERROR MESSAGES THAT DISPLAYED. THE TOUCHSCREEN ON THE EDWARDS EV1000 PC PANEL DID NOT RESPOND. THERE WAS A TOUCHSCREEN FAILURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538784 EV1000A PLATFORM EV1000A PLATFORM DXG EDWARDS LIFESCIENCES LLC EV1000A 64505539-7

    Patients

    Seq Age Sex Outcome Treatment
    1