BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 8910671 · Received August 20, 2019

    Report

    Report Number
    2021710-2019-10685
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    July 25, 2019
    Report Date
    July 25, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED AND WAS ISOLATED TO THE PT800 THAT HAS FAILED. CAPA CA-2017-0206 WAS INITIATED TO ADDRESS THIS ISSUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE AND REPLACED THE MAIN BOARD. THE FSR PERFORMED THE OPERATOR VERIFICATION PROCEDURE (OVP) AND CALIBRATION, ALL PASSED. THE FIELD SERVICE REPRESENTATIVE CONFIRMED THE VENTILATOR MET ALL VYAIRE MANUFACTURER SPECIFICATIONS. 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

    THE CUSTOMER REPORTED TO VYAIRE THAT THE VELA VENTILATION WAS NOT WORKING AND WOULD NOT VENTILATE. THE VENTILATOR SHOWS A "VENT INOP" MESSAGE. THE CUSTOMER STATED THERE WAS PATIENT INVOLVEMENT; HOWEVER NO FURTHER DETAILS WERE AVAILABLE WHEN THE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702630 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1 Other