BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 3972799 · Received July 28, 2014

    Report

    Report Number
    MW5037523
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 25, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VENTILATOR READING LOW EXHALED TIDAL VOLUMES - 336. SET TIDAL VOLUME FOR 450 ML. REQUIRED MANUAL VENTILATION TO MEET PT DEMAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438544 VELA VENTILATOR VENTILATOR CBK CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention