BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABLATION CONSOLE

    MDR report key: 1395401 · Received May 15, 2009

    Report

    Report Number
    1395401
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 2, 2009
    Report Date
    May 15, 2009
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO USE CRYOABATION ON VENTRICULAR TACHYCARDIAC (VT) PT. SYSTEM GAVE HIGH REFRIGERANT FLOW ERROR. CRYOCATH UMBILICAL CORD AND CATHETER EXCHANGED, TROUBLESHOOTING AND ERROR MESSAGE REMAINED. UNIT REMAINED ON FOR A TOTAL OF APPROX 25 MINS AND CONTINUED TO GIVE ERROR MESSAGE WHEN ABLATION WAS ATTEMPTED. UNIT WAS REPLACED WITH CRYOCATH UNIT FROM PEDS DEPT AND ABLATION WAS SUCCESSFULLY ADMINISTERED AFTER APPROX 1 MIN OF WARM-UP TIME. CASE DELAYED APPROX 30MINS.====================== MANUFACTURER RESPONSE FOR ABLATION UNIT, ABLATION UNIT======================DEVICE TESTED BY VENDOR BUT COULD NOT REPRODUCE PROBLEM. REPLACED THE VALVE BOARD AND THE PROPORTIONAL VALVE RESPONSIBLE FOR REFRIGERANT DELIVERY IN CASE THERE IS AN INTERMITTENT PROBLEM. CONSOLE IS WORKING PROPERLY AND NO PROBLEMS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABLATION CONSOLE ABLATION CONSOLE NFC CRYOCATH TECHNOLOGIES, INC. 10000003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR