BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEL

    MDR report key: 3867486 · Received June 11, 2014

    Report

    Report Number
    2031702-2014-00151
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GAVE THREE BREATHS AND THEN NO FLOW WITH AN AUDIBLE ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS MANUALLY VENTILATED FOR THE REMAINDER OF THE FLIGHT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344660 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention