BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 7108424 · Received December 11, 2017

    Report

    Report Number
    MW5073905
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    December 8, 2017
    Report Date
    December 8, 2017
    Manufacturer
    CAREFUSION / VYAIRE MEDICAL INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) MALE NICU PT ON A CAREFUSION AVEA VENTILATOR REQUIRED INTERVENTION WHEN VENTILATOR SPONTANEOUSLY STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883604 CAREFUSION AVEA VENTILATOR CBK CAREFUSION / VYAIRE MEDICAL INC. AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 DA Required Intervention