BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 20690984 · Received November 14, 2024

    Report

    Report Number
    3013421741-2024-00529
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 14, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: LOGS WERE SUBMITTED TO TECHNICAL SERVICE FOR ASSESSMENT. FOLLOWING THEIR REVIEW, TECHNICAL SERVICE ADVISED REPLACING THE O2 VALVE. THREE SUBSEQUENT ATTEMPTS WERE MADE TO REACH THE CUSTOMER TO VERIFY WHETHER THE ISSUE WAS RESOLVED AFTER THE VALVE REPLACEMENT; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER TO DATE. A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CGR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BELLAVISTA 1000 VENTILATOR O2 SUPPLY IS CONNECTED AND 02 VALVE IS OPEN, A LEAKING NOISE FROM THE RIGHT SIDE OCCURS. PATIENT INVOLVEMENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350654 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL 301.100.000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown