BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC NAUTILUS OXYGENATOR

    MDR report key: 20631748 · Received November 6, 2024

    Report

    Report Number
    MW5162300
    Event Type
    Other
    Date Received
    November 6, 2024
    Report Date
    November 4, 2024
    Manufacturer
    MEDTRONIC / MC3, INC.
    Product Code
    BYS
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ECMO OXYGENATOR FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539485 MEDTRONIC NAUTILUS OXYGENATOR OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS BYS MEDTRONIC / MC3, INC. 481043347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male