BEUDAMED
    FDA Adverse Event Death Summary report: N

    VELA VENTILATOR

    MDR report key: 12990634 · Received December 13, 2021

    Report

    Report Number
    2021710-2021-15033
    Event Type
    Death
    Date Received
    December 13, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 15, 2021
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PATIENT WAS ON THE DEVICE AND WOULD PERIODICALLY DISCONNECT HERSELF FROM THE VENTILATOR RESULTING IN PATIENT EXPIRING ON THE VELA VENTILATOR, THE DEVICE ALARMED AS IT SHOULD AND NO ONE IS BLAMING THE VENTILATOR FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881993 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death