BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYO TANK

    MDR report key: 12778516 · Received November 9, 2021

    Report

    Report Number
    12778516
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 14, 2021
    Report Date
    October 27, 2021
    Manufacturer
    PRAXAIR DISTRIBUTION, INC.
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AFTER CHANGING OUT THE CRYO TANK, THE CRYOABLATION MACHINE STOPPED WORKING. IT WAS FOUND THAT NITRIC OXIDE TANK CONTAINS THE WRONG GAS. THE CYRO TANK SHOULD HAVE NON-MEDICAL GRADE AIR. IT CONTAINED MEDICAL GRADE NITRIC OXIDE, WHICH IS USED BY ANESTHESIA. BOTH TANKS WERE APPROPRIATELY LABELED AND ARE SPECIFIC TO THE CRYOABLATION CONSOLE. THIS INCORRECT GAS CAUSED THE CONSOLE TO MALFUNCTION. ONCE THE CORRECT GAS FROM ANOTHER TANK WAS HOOKED UP AND TESTED, THE MACHINE WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676247 CRYO TANK ECX PRAXAIR DISTRIBUTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown