BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTILATOR

    MDR report key: 13691771 · Received March 7, 2022

    Report

    Report Number
    MW5107914
    Event Type
    Death
    Date Received
    March 7, 2022
    Date of Event
    February 19, 2022
    Report Date
    March 3, 2022
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    UDI-DI
    07630002801850
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON THE MORNING OF (B)(6) 2022, STAFF WERE PREPARING TO MOVE THE PATIENT FROM THE ICU FOR A RADIOLOGY PROCEDURE. THE PATIENT WAS ON A VENTILATOR IN THE ICU AND WAS TRANSITIONED TO A TRANSPORT VENTILATOR FOR THE MOVE TO RADIOLOGY. SHORTLY AFTER CONNECTION TO THE TRANSPORT VENTILATOR, STAFF NOTED A DECLINE IN PATIENT'S CARDIORESPIRATORY STATUS. RESUSCITATION EFFORTS WERE INITIATED BUT WERE UNSUCCESSFUL. FDA SAFETY REPORT ID#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527281 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK HAMILTON MEDICAL, INC. T1 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Death