BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEZOR XTRA 3

    MDR report key: 1221643 · Received October 26, 2008

    Report

    Report Number
    1221643
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    October 26, 2008
    Manufacturer
    CRYOCATH TECHNOLOGIES INC.
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EVERY TIME PHYSICIAN CAME ON TO ABLATE THERE WOULD BE AN ERROR MESSAGE STATING REFRIGERANT TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR XTRA 3 CATHETER, CRYOABLATION, CARDIAC OAD CRYOCATH TECHNOLOGIES INC. NA 02548

    Patients

    Seq Age Sex Outcome Treatment
    1 *