BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 4905225 · Received June 24, 2015

    Report

    Report Number
    4905225
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 24, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST AT THE BEDSIDE OF A THREE MONTH OLD INFANT IN NICU. THE VIASYS AVEA SCREEN WENT BLANK. THE RESPIRATORY THERAPIST COULD NOT HEAR THE VIASYS AVEA VENTILATOR CYCLE. THE THREE MONTH OLD INFANT WAS REMOVED FROM THE VIASYS AVEA. THE RESPIRATORY THERAPIST MANUALLY VENTILATED THE PATIENT UNTIL ANOTHER VIASYS AVEA VENTILATOR COULD BE BROUGHT TO THE BEDSIDE AND SETUP. THE INFANT'S HEART RATE AND OXYGEN SATURATION REMAINED STABLE. NO UNTOWARD PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408687 AVEA VENTILATOR, CONTINUOUS, FACILITY CBK CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO