BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 22309908 · Received June 23, 2025

    Report

    Report Number
    3013421741-2025-01604
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 3, 2025
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    UDI-DI
    07640149381115
    PMA / PMN Number
    K183364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LOG FILES WERE PROVIDED TO ZOLL FOR EVALUATION, HOWEVER, THERE WERE NO CONCERNING TECHNICAL FAILURES FOUND IN THE LOGS RELATED TO THE REPORTED MALFUNCTION. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO EVALUATE THE DEVICE. THE FSE WAS UNABLE TO CONFIRM OR DUPLICATE THE REPORTED MALFUNCTION DURING THE EVALUATION. THE DEVICE PASSED A FULL CALIBRATION, CIRCUIT AND VERIFICATION TESTING WITH NO ISSUES FOUND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE DEVICE WAS IN USE, THE FLOW SENSOR ON THE DEVICE MADE AN UNUSUAL NOISE AND WAS DELIVERING VOLUMES HIGHER THAN SET. THE RESPIRATORY THERAPIST PLACED THE PATIENT ON BIPAP AND THE DEVICE DISPLAYED A BREATHING RATE OF 115. THE DEVICE WAS MAKING A "SPUTTERING" SOUND WHILE APPLIED ON PATIENT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970513 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 301.100.030 NA 07640149381115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown