BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 21358869 · Received February 11, 2025

    Report

    Report Number
    3013421741-2025-00604
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 16, 2025
    Report Date
    February 11, 2025
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FILE IDENTIFICATION: (B)(4) D4: UNIQUE IDENTIFIER (UDI) #- UNABLE TO COMPLETE ENTIRE UDI# AS THE MANUFACTURING DATE INFORMATION WAS NOT RECEIVED. H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: G3, G6, H2, H6, AND H11 RESULTS OF INVESTIGATION: SINCE NEITHER THE SUSPECT DEVICE NOR READABLE LOGS WERE RETURNED TO VYAIRE MEDICAL FOR EVALUATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. AS A RESULT, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CGR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BELLAVISTA DISPLAYED A TF 388 ERROR. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793940 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL 301.100.030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown