BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 18522382 · Received January 16, 2024

    Report

    Report Number
    3004553423-2024-02128
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    December 10, 2023
    Report Date
    January 16, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    07640149380019
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED TO VYAIRE MEDICAL FOR EVALUATION. THE ROOT CAUSE WAS DETERMINED DUE TO DEFECTIVE INSPIRATION VALVE NT. AFTER REPLACING THE INSP. BLOCK, VENTILATOR RECALIBRATED AND PASSED.

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION:(B)(4). H10: THE SUSPECT DEVICE HAS NOT BEEN RETURN FOR INVESTIGATION. VYAIRE TS HAS CONFIRMED THAT THERE IS A LEAK WHEN PERFORMING THE TEST. AS A RESOLUTION, VYAIRE TS ADVISED THAT THE NT VALVE NEEDS TO BE REPLACED. FURTHERMORE, NO ROOT CAUSE HAS 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 · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 VENTILATOR HAD ERROR 401. 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
    1001770 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL BELLAVISTA1000 VENTILATOR 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown