BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 13573238 · Received February 21, 2022

    Report

    Report Number
    2021710-2022-15564
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    January 24, 2022
    Report Date
    January 24, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). VYAIRE FIELD SERVICE WENT ONSITE INSPECTED THE UNIT FOUND LOW VE (VENTILATION) AND LOW PIP (POSITIVE INSPIRATORY PRESSURE) ALARMS IN THE EVENTS MENU. AS A RESOLUTION PERFORMED MULTIPLE LEAK TEST AND PERFORMED UVT (USER VERIFICATION TEST) UNIT PASSED. PERFORMED VERIFICATION TEST THE UNIT IS WITHIN MANUFACTURER SPECIFICATION AND UNIT HOURS IS 606. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). VYAIRE FIELD SERVICE WENT ONSITE INSPECTED THE UNIT FOUND LOW VE (VENTILATION) AND LOW PIP (POSITIVE INSPIRATORY PRESSURE) ALARMS IN THE EVENTS MENU. AS A RESOLUTION PERFORMED MULTIPLE LEAK TEST AND PERFORMED UVT (USER VERIFICATION TEST) UNIT PASSED. PERFORMED VERIFICATION TEST THE UNIT IS WITHIN MANUFACTURER SPECIFICATION AND UNIT HOURS IS 606. 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 TO VYAIRE MEDICAL THAT THE VELA VENTILATOR WAS NOT DELIVERING BREATH. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR WAS NOT DELIVERING BREATH. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65453 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown