BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR SYSTEM

    MDR report key: 2440996 · Received February 2, 2012

    Report

    Report Number
    3001627457-2011-00006
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    August 8, 2011
    Report Date
    February 21, 2012
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K081467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: COMPLETE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE BECAUSE THE DEVICE WAS NOT RETURNED FOR EVAL. BASED ON INFO FROM THE USER AND THE EVENT LOG, THE INCIDENT IS CONSISTENT WITH A FRACTURED RF WIRE. THE EVENT LOG DOCUMENTS THAT THE CONTROL UNIT MONITORED TEMPERATURES CORRECTLY AND TOOK APPROPRIATE ACTION. THE DEVICE WAS REMOVED WITHOUT INCIDENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EKOSONIC ENDOVASCULAR SYSTEM CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 106CM / 40CM 110511001-001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR