BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 19407395 · Received May 28, 2024

    Report

    Report Number
    3013421741-2024-00130
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 28, 2024
    Manufacturer
    VYAIRE MEDICAL INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: COM (B)(4). 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. H3 OTHER TEXT : ON-SITE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT AFTER DOING THE CALIBRATIONS THE VENT HAS CIRCUIT DISCONNECT. IT WAS SUGGESTED TO PERFORM EXP, INSP PRESSURE TRANSDUCER CALIBRATIONS AND EXP FLOW TRANSDUCER. BOTH CALIBRATIONS WERE PERFORMED TWICE. WATER TRAP/FILTER WERE CHANGED. NEXT STEP IS TO REPLACE GDE. CUSTOMER REQUESTED FSE TO PERFORM REPAIR. A QUOTE IS BEING CREATED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328771 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC 32029-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown