BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 10954250 · Received December 5, 2020

    Report

    Report Number
    2021710-2020-12982
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 12, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446000016
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. 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

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR OXYGEN WILL NOT GO DOWN TO 21%, THE LOWEST IT WILL GO IS 26%. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417092 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA 10846446000016

    Patients

    Seq Age Sex Outcome Treatment
    1