BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 18234570 · Received November 29, 2023

    Report

    Report Number
    3004553423-2023-02061
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 6, 2023
    Report Date
    November 29, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3:81 OTHER: THE SUSPECT DEVICE HAS NOT BEEN RETURN FOR INVESTIGATION. FURTHERMORE, NO ROOT CAUSE HAS BEEN DETERMINED YET. BUT, LOGS PROVIDED SHOWS A LOT OF PLV (PRESSURE-LIMITED VENTILATION), OCCLUSION AND HIGH PRESSURE ALARMS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED TO VYAIRE MEDICAL FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULDN'T BE DETERMINED. NO PROBLEM DETECTED. PLV ALARMS ARE VISIBLE ON THE LOGS TOGETHER WITH OCCLUSION ALARMS. WITH THE AVAILABLE DATA FROM THE LOGS, THE ISSUE APPEARED WITH ADULT PATIENTS. THE SET TIDAL VOLUME WAS NOT ACHIEVABLE WITH THE MAXIMUM ALLOWED AIRWAY PRESSURE (PPEAK UPPER ALARM LIMIT -5MBAR), THEREFORE THE PLV (PRESSURE LIMITED VENTILATION) LUNG PROTECTION SAFETY FEATURE HAS KICKED-IN AS DESIGNED AND THE MACHINE HAS ALARMED ACCORDINGLY ALARM 105 - "VOLUME LOW (PLV PRESSURE-LIMITED)".

    Description of Event or Problem · 0

    A BIOMED MANAGER REPORTED TO VYAIRE MEDICAL THAT A BELLAVISTA1000 US VENTILATOR HAD A PRESSURE READING OF 0CMH20. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772880 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown