BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000 PLATFORM

    MDR report key: 4953695 · Received July 30, 2015

    Report

    Report Number
    2015691-2015-01903
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 2, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K100709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE POWER SUPPLY OF THE SYSTEM WAS CONNECTED TO THE POWER CORD AND BLACK SMOKE WAS OBSERVED. THE CORD ALSO SMELT BURNT. THE MONITOR AND DATABOX DID WORK WITH THE CORD CONNECTED. THE SYSTEM PASSED ALL PERFORMANCE TESTS WITH A NEW POWER SUPPLY. POSSIBLE ROOT CAUSE: WATER OR LIQUID PENETRATED POWER SUPPLY. IT APPEARS THAT WATER OR LIQUID PENETRATED THE POWER CABLE, CAUSING THE SMOKE OBSERVED DURING THE PRODUCT EVALUATION. THERE WAS NO REPORT FROM THE CUSTOMER OF ANY SMOKE OR BURNING SMELL. THE CORD IS BEING DISCARDED. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE OF INTERRUPTED POWER SUPPLY: NO ADDITIONAL INFORMATION WAS REPORTED BY THE CUSTOMER. DURING EVALUATION OF THE SUBJECT DEVICE, IT WAS FOUND THAT THERE WAS BLACK SMOKE COMING FROM THE POWER CORD; IT ALSO SMELT BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497787 EV1000 PLATFORM COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES EV1000A EV003470

    Patients

    Seq Age Sex Outcome Treatment
    1