BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 5400577 · Received January 30, 2016

    Report

    Report Number
    2021710-2016-02796
    Event Type
    Malfunction
    Date Received
    January 30, 2016
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION THAT IS PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE COMPONENT FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXHALED HIGH PEAK PRESSURE (EXH HIGH PPEAK) AND CIRCUIT OCCLUSION. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT OR ALLEGATION OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59028 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA STD

    Patients

    Seq Age Sex Outcome Treatment
    1