BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 10737830 · Received October 26, 2020

    Report

    Report Number
    2021710-2020-12750
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001389
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. HOWEVER, THE CUSTOMER PERFORMED TRANSDUCER TESTS AND FOUND EXHL DIFF. TESTS FAILED. ALSO CARRIED OUT TRANSDUCER CALIBRATION AND FOUND THAT THE EXHALATION DIFF FAILED AT 0CMH2O. ACCORDING TO THE CUSTOMER, THE MAIN PCB BOARD NEEDS TO BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS GIVING INTERMEDIATELY POST DIGITAL TO ANALOG CONVERTER (DAC) OR ANALOG TO DIGITAL CONVERTER (ADC) ERROR, MOTOR FAULT ALARM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202492 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001389

    Patients

    Seq Age Sex Outcome Treatment
    1