BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 11688719 · Received April 19, 2021

    Report

    Report Number
    2021710-2021-13775
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 22, 2021
    Report Date
    March 22, 2021
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: G3, G6, H2, H3, H6 AND H10. RESULT OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED COMPLAINT WAS CONFIRMED AND DUPLICATED. THE ROOT CAUSE IS A FAULTY TRANSDUCER SENSOR. THIS IS A KNOWN ISSUE WHICH CAN BE REFERENCED WITH CAPA CA-2017-0206.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. 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 MEDICAL THAT THE WHEN THE VELA VENTILATOR WAS POWERED ON, HIGH PIP (PEAK INSPIRATORY PRESSURE), LOW VE(VENTILATION), XDCR (TRANSDUCER) FAULT, HIGH RATE, LOW VE (MINUTE VENTILATION), AND LOW PIP (PEAK INSPIRATORY PRESSURE) ALARMS TRIGGERED. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584738 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention