BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 9379943 · Received November 26, 2019

    Report

    Report Number
    2021710-2019-11079
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 1, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446000047
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4). DEVICE EVALUATION: D10, G4, G7, H2, H3, H6, H10. RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE GAS DELIVERY ENGINE (GDE) AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED OR DUPLICATED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE COMPLAINT #: (B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE AVEA VENTILATOR EXPERIENCED LOW FIO2 WHILE IN USE ON A PATIENT. THE CUSTOMER ADVISED THE PATIENT WAS MOVED TO ANOTHER VENTILATOR AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174012 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA 10846446000047

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention