BEUDAMED
    FDA Adverse Event Death Summary report: N

    BELLAVISTA

    MDR report key: 22840346 · Received August 19, 2025

    Report

    Report Number
    3013421741-2025-01672
    Event Type
    Death
    Date Received
    August 19, 2025
    Date of Event
    July 30, 2025
    Report Date
    July 30, 2025
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K183364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE CUSTOMER WAS ABLE TO PROVIDE LOGFILES FOR FURTHER EVALUATION. THE DATA SHOWS THAT THE DEVICE WAS IN USE FROM (B)(6) 2025, AT 15:44:33 THROUGH (B)(6) 2025, AT 07:25:30. DURING THIS TIME, BOTH THE LOG AND TREND FILES DOCUMENTED FLUCTUATIONS IN FIO2 VALUES. AT 07:18, THE TREND FILES DOCUMENTED MULTIPLE DIPS IN MONITORED FIO2 VALUES ACCOMPANIED BY ELEVATED LEAK FLOW. GIVEN THE AMOUNT OF LEAK FLOW PRESENT IN THE TREND FILES, THE SEAL OF THE PATIENT INTERFACE WAS LIKELY POOR, WHICH RESULTED IN AIR ENTRAINMENT. AS A RESULT, A REDUCED MEASUREMENT IN FIO2 CONCENTRATION WOULD BE SEEN, AS EXPERIENCED BY THE CLINICIAN DURING THIS PATIENT EVENT. GIVEN THE CIRCUMSTANCES OF THE POOR PATIENT SEAL, THE DEVICE BEHAVED APPROPRIATELY. THE DEVICE WAS EVALUATED BY A ZOLL FIELD SERVICE ENGINEER (FSE) AND WAS FOUND TO BE OPERATING WITHIN CALIBRATION AND TESTING SPECIFICATIONS. THROUGH THE DEVICE LOG FILE REVIEW AND PHYSICAL EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE DEVICE WAS OPERATING AS INTENDED AND THE DEVICE MEETINGS SPECIFICATION. NO TREND IDENTIFIED BASED ON SIMILAR EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE ALARM OCCURRED INDICATING A FIO2 DOSING ISSUE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284950 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 301.100.030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death