BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYO MAJE

    MDR report key: 748512 · Received July 11, 2005

    Report

    Report Number
    MW1036042
    Event Type
    Other
    Date Received
    July 11, 2005
    Date of Event
    June 28, 2005
    Report Date
    June 29, 2005
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    GEN
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRYO MAJE MACHINE FAILED DURING PROCEDURE - COMPANY CALLED AND ALL EQUIPMENT WAS HOOKED UP CORRECTLY. ATTEMPTED TO USE MACHINE DURING OPEN HEART PROCEDURE, PROBE CHANGED AND STILL MACHINE DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO MAJE TISSUE FREEZING GEN CRYOCATH TECHNOLOGIES, INC. 10000-04-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other