BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA

    MDR report key: 8938025 · Received August 27, 2019

    Report

    Report Number
    2021710-2019-10723
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    July 29, 2019
    Report Date
    July 30, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001358
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ON-SITE TO EVALUATE THE SUSPECT DEVICE. THE FSR REPLACED THE MAIN POWER SWITCH ASSEMBLY AND PERFORMED THE OPERATIONAL VERIFICATION PROCEDURE. THE FSR REPORTED THE DEVICE PASSED ALL PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VELA VENTILATOR WAS ON A PATIENT WHEN THE HUSBAND OF THE PATIENT SAID HE HEARD THE DEVICE MAKE AN ODD NOISE. THE SCREEN WENT BLANK FOR A SECOND THEN POPPED BACK ON IN THE "SELECT PATIENT" SCREEN. THE CUSTOMER REPORTED THE ATTENDING RESPIRATORY THERAPIST PUSHED THE RESUME PATIENT ICON AND DEVICE WENT BACK INTO THE CORRECT PREVIOUS SETTINGS. THE CUSTOMER REPORTED THE UNIT STARTED VENTILATING WITH NO PROBLEMS. AS A PRE-CAUTIONARY MEASURE, THEY PLACED THE PATIENT ON ANOTHER VENTILATOR. THE CUSTOMER REPORTED THERE IS NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730926 VELA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention