BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 12355817 · Received August 23, 2021

    Report

    Report Number
    2021710-2021-14406
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 26, 2021
    Report Date
    July 26, 2021
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    10846446000641
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. HOWEVER, THE CUSTOMER STATED THAT THEY CHANGED THE O2 (OXYGEN) SENSOR 3X BUT THERE'S STILL NO CHANGE. TH TECHNICAL SUPPORT INFORMED THEM THAT IT MAY BE A DELIVERED PROBLEM AND RECOMMENDED PERFORMING A BLENDER CALIBRATION. SINCE UNIT WAS ALSO ALARMING INVALID GAS ID THE TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT THE AIR SMART CONNECTOR NEEDS TO BRA REPLACED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR WAS HAVING FIO2 (FRACTION OF INSPIRED OXYGEN) INACCURACY AND INVALID GAS ID. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252592 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. AVEA 10846446000641

    Patients

    Seq Age Sex Outcome Treatment
    1