BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 18026384 · Received October 27, 2023

    Report

    Report Number
    3004553423-2023-02018
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 27, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE SUSPECT DEVICE HAS NOT BEEN RETURN FOR INVESTIGATION. HOWEVER, LOG ANALYSIS SHOWS THAT THERE WAS NO OCCLUSION ALARM APPEAR BUT A PERSIST PLV ALARM 196. 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.

    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. PLV ALARMS ARE VISIBLE ON THE LOGS TOGETHER WITH OCCLUSION ALARMS. 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

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 US VENTILATOR WAS HAVING PERSISTENT OCCLUSION ALARM ON (B)(6) WHILE ON A PATIENT. FURTHERMORE, PATIENT WAS REMOVED FROM THE MACHINE WITH NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952784 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention