BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 9261867 · Received October 31, 2019

    Report

    Report Number
    2021710-2019-10971
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    October 4, 2019
    Report Date
    July 28, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS TEAM DETERMINED THE REPORTED COMPLAINT WAS CONFIRMED THROUGH THE EVENTS LOG AND DUPLICATED DURING FUNCTIONAL CHECK. TRANSDUCERS PT800 AND PT802 HAVE FAILED. THE CUSTOMER WAS SHIPPED A REPLACEMENT PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. 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 · 1

    IT WAS REPORTED TO VYAIRE THAT THE VELA VENTILATOR EXPERIENCED "LOW VE", "HIGH RATE", "LOW PIP" AND "LOW VE" WHILE IN USE ON A PATIENT. THE PATIENT WAS MOVED TO ANOTHER VENTILATOR. THE CUSTOMER ADVISED THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057985 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention