BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEZOR XTRA 3

    MDR report key: 1358844 · Received March 24, 2009

    Report

    Report Number
    1358844
    Event Type
    Malfunction
    Date Received
    March 24, 2009
    Date of Event
    January 22, 2009
    Report Date
    March 24, 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

    HIGH REFRIGERANT FLOW ERROR. CHANGED UMBILICAL CORD AND CATHETER / ERROR MESSAGE WAS NOT RESOLVED. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR XTRA 3 CATHETER, ABLATION, CRYO NFC CRYOCATH TECHNOLOGIES INC. * 03453

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR