BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 6736493 · Received July 24, 2017

    Report

    Report Number
    2021710-2017-06342
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 26, 2017
    Report Date
    July 24, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE TRAINED CUSTOMER REPORTED THE SUSPECT DEVICE WAS BEING RE-WORKED AND HAS NOT REQUESTED A RETURN GOOD AUTHORIZATION (RGA) FOR A COMPONENT/DEVICE ANALYSIS. AT THIS TIME, CAREFUSION DOES NOT ANTICIPATE AN EVALUATION HOWEVER, IF AN RGA IS ISSUED IT WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNRESOLVED CIRCUIT DISCONNECT ALARM WHILE IN USE ON THIS AVEA VENTILATOR. NO KNOWN REPORT OF ANY PATIENT HARM ASSOCIATED WITH THIS EVENT. THE HOSPITAL BIOMED REPORTED PASSING THE LEAK TEST AND NOT BEING ABLE TO DUPLICATE THE REPORTED END USER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516777 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention