BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 8910676 · Received August 20, 2019

    Report

    Report Number
    2021710-2019-10681
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    July 22, 2019
    Report Date
    July 22, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT#: (B)(4). RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED AND DUPLICATED. THE REPORTED PROBLEM WAS ISOLATED TO A COMPONENT FAILURE, SPECIFICALLY THE PT800 TRANSDUCER FAILED. THIS ISSUE WAS ADDRESSED WITH CAPA: CA-2017-0206. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE COMPLAINT #: (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 HIGH PI, LOW VE, AND APNEA INTERVAL ALARMED WHILE IN USE ON A PATIENT. THE EVENTS LOG RECORDED "TRANSDUCER FAULT OCCURRED". THE TRANSDUCER TEST WAS PERFORMED AND "TURB DIFF: 34 FAILED". THE CUSTOMER ADVISED THERE WAS NO PATIENT HARM AND THE PATIENT WAS MOVED TO A DIFFERENT VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703043 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention