BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 24993155 · Received April 26, 2026

    Report

    Report Number
    3013421741-2026-00172
    Event Type
    Malfunction
    Date Received
    April 26, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 6, 2026
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    UDI-DI
    10190752197664
    PMA / PMN Number
    K183364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE VENTILATOR DISPLAYED A BLACK SCREEN ACCOMPANIED BY RED AND YELLOW FLASHING LIGHT-EMITTING DIODES. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497766 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 301.100.032 NA 10190752197664

    Patients

    Seq Age Sex Outcome Treatment
    1