BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 9193817 · Received October 15, 2019

    Report

    Report Number
    2021710-2019-10915
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 19, 2019
    Report Date
    September 19, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4). CORRECTION: H2, H10 RESULTS OF FIELD SERVICE REPRESENTATIVE ONSITE VISIT: A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE AND REPLACED THE TURBINE. THE FSR PERFORMED THE OPERATIONAL VERIFICATION PROCEDURE (OVP) AND TEST ALL PASSED PER SERVICE MANUAL. THE FIELD SERVICE REPRESENTATIVE CONFIRMED THE VENTILATOR MET ALL VYAIRE MANUFACTURER SPECIFICATIONS. RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED PROBLEM WAS DUPLICATED AND ISOLATED TO A FAILED BEARING. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4). THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED PROBLEM WAS DUPLICATED AND ISOLATED TO A FAILED BEARING. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 STOPPED VENTILATING WHILE IN USE ON A PATIENT. THE CUSTOMER STATED THE 100% BUTTON ON THE VENTILATOR IS NOT WORKING AND NO VOLUMES WERE BEING DELIVERED. ADDITIONALLY, THE CUSTOMER STATED THE HEATED MOISTURE EXCHANGE WAS VERY DISCOLORED GRAY AND MAY HAVE BEEN AN ISSUE WITH RESTRICTION OF FLOW. THE CUSTOMER ADVISED THE PATIENT WAS MOVED TO A DIFFERENT VENTILATOR AND THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987582 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention