BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2436580 · Received January 9, 2012

    Report

    Report Number
    2436580
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    August 9, 2011
    Report Date
    January 6, 2012
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    ICU STAFF REPORTED DEVICE "NOT FUNCTIONING" AND CALLED EKOS HELP LINE TO TROUBLESHOOT THE SYSTEM. PATIENT WAS RETURNED TO SURGERY TO HAVE THE CATHETERS REMOVED. THE CASE CONTINUED SUCCESSFULLY AND NO KNOWN HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, CONTINUOUS FLSUH KRA EKOS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR