BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 5693647 · Received June 1, 2016

    Report

    Report Number
    2031702-2016-00708
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Date of Event
    May 6, 2016
    Report Date
    May 6, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB EXAMINED THE GAS DELIVERY ENGINE(GDE) INSTALLED IN A KNOWN GOOD AVEA TEST STATION AND POWERING THE GDE IN A AVEA UNIT THE REPORTED ISSUE WAS NOT DUPLICATED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DUPLICATED, THE GDE MEETS FACTORY SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4). A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ON SITE AND REPLACED THE GAS DELIVERY ENGINE (GSE) IN ORDER TO RESOLVE THE REPORTED ISSUE. THE DEVICE WAS TESTED AND RETURNED TO THE CUSTOMER WORKING TO SERVICE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE AVEA VENTILATOR, IT ALARMED EXT HIGH PPEAK. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347434 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AVEA STD

    Patients

    Seq Age Sex Outcome Treatment
    1