BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 10872229 · Received November 19, 2020

    Report

    Report Number
    2021710-2020-12890
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001501
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). A FIELD SERVICE REPRESENTATIVE EVALUATED THE DEVICE. IN TESTING FOUND THE EXHALATION VALVE WOULD LET FLOW PASSED IT AT A PEEP HIGHER THAN 19 CMH2O. EXHALATION VALVE AND TRANSDUCERS WAS CALIBRATED BUT THE ISSUE REMAINED. THE EXHALATION VALVE WAS REPLACED AND CALIBRATED TRANSDUCERS AND EXHALATION VALVE. PERFORMED OPERATIONAL VERIFICATION PROCEDURE. VENTILATOR MEETS FACTORY SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR DO NOT REGISTER PEAK PRESSURES AND THERE IS AN ISSUE WITH THE INSPIRATION HOD BUTTON. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336030 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001501

    Patients

    Seq Age Sex Outcome Treatment
    1