BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC

    MDR report key: 7032498 · Received November 15, 2017

    Report

    Report Number
    7032498
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 13, 2017
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EKOS MACHINE STARTED ALARMING THROUGH THE NIGHT. SERVICE CALLED, BUT COULD NOT FIX PROBLEM VIA PHONE CALL. EKOS MACHINES TURNED OFF, AND TISSUE PLASMINOGEN ACTIVATOR (TPA) AND COOLANT DELIVERY CONTINUED VIA SIGMA PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813238 EKOSONIC CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 6779-001 170124057-005 AND 151008027-0

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR NO| NO OTHER THERAPIES