BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 23116655 · Received September 22, 2025

    Report

    Report Number
    3013421741-2025-01709
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 24, 2025
    Report Date
    September 2, 2025
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    UDI-DI
    07640149381115
    PMA / PMN Number
    K183364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED CLARIFICATION THAT THE PATIENT WAS BEING VENTILATED IN NON-INVASIVE VENTILATION (NIV) MODE AND THE DEVICE BEGAN TO TRIGGER MORE BREATHES THAN NECESSARY AND BEGAN TO STACK. THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION, BUT THEY DID SUPPLY THE DEVICE LOGS FOR REVIEW. UPON REVIEW OF THE VENTILATOR LOGS AND TRENDING DATA, TECH SUPPORT DID NOT FIND ANY INDICATION THAT THE VENTILATOR SWITCHED MODES AUTOMATICALLY. UPON FURTHER ANALYSIS, INCONSISTENT WAVEFORMS AND AUTO-CYCLING ACTIVITY WERE OBSERVED DURING THE TIME OF THE REPORTED EVENT. THE REPORTED SYMPTOMS ARE CONSISTENT WITH FALSE TRIGGERING DURING NON-INVASIVE VENTILATION (NIV) WHICH USUALLY OCCURS WHEN THERE IS AN EXCESSIVE LEAK OR CIRCUIT SETUP VARIATION AROUND THE PATIENT INTERFACE CAUSING THE VENTILATOR TO INTERPRET LEAK FLOW AS A PATIENT EFFORT AND DELIVER UNINTENDED ADDITIONAL BREATHS. AFTER THIS, THE DEVICE WAS TESTED WITHOUT DUPLICATING THE REPORTED ISSUE AND THE VENTILATOR OPERATED AS DESIGNED WITH NO DEVICE REPAIR REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE VENTILATOR SWITCHED FROM NON-INVASIVE VENTILATION (NIV) ON ITS OWN. AN ALTERNATIVE DEVICE WAS EXCHANGED, AND NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202017 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 301.100.030 NA 07640149381115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown