BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 18846199 · Received March 6, 2024

    Report

    Report Number
    2021710-2024-18847
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 13, 2024
    Report Date
    March 6, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001358
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: A VYAIRE FIELD SERVICE REPRESENTATIVE(FSR) EVALUATED THE DEVICE ONSITE AND CHECKED THE FLOW SENSOR RECEPTACLE AND EXHALATION VALVE. THE O-RINGS AND COVER WERE INTACT BUT THE DIAPHRAGM IN THE EXHALATION VALVE WAS NOT FULLY SECURED AND FLUSHED. THE DIAPHRAGM WAS ADJUSTED TO SIT INSIDE OF THE EXHALATION VALVE. THE FSR TESTED THE UNIT USING THE CUSTOMER CIRCUIT,CHECKED THE EVENTS AND FOUND ALARMS OF CIRCUIT DISCONNECT,HIGH RATE AND LOW VE (MINUTE VENTILATION) WHICH IS TO BE SEEN IF CIRCUIT DISCONNECT IS PRESENT, TESTED THE UNIT AND FOUND THAT THE VOLUMES AND VE WERE WITHIN SPECIFICATIONS. BLENDING ACCURACY WAS PERFORMED AND EACH FI02 (FRACTION OF INSPIRED OXYGEN) SETTINGS WERE WITHIN SPECIFICATION. OVP (OPERATIONAL VERIFICATION PROCEDURE) WAS DONE. THE UNIT PASSED ALL TESTS AND RUNS ACCORDING TO OEM (ORIGINAL EQUIPMENT 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 · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR TIDAL VOLUME IS LOW. FURTHERMORE, THERE WAS NO INFORMATION FOR PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102267 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown