BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 14627001 · Received June 7, 2022

    Report

    Report Number
    2021710-2022-16069
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 10, 2022
    Report Date
    May 10, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE(FSR) EVALUATED THE DEVICE ONSITE. THE FSR FOUND THAT THE UNIT WAS NOT PASSING PRE CHECK AND THE VOLUME AND PRESSURES WERE LOW ON ARRIVAL. UPON INSPECTION, THE TUBING WAS FOUND TO BE WEAK,CRACKED AND LEAKING. THE TUBING WAS REPLACED AND OPERATIONAL VERIFICATION PROCEDURE WAS PERFORMED AND THE UNIT PASSED. THE UNIT OPERATES TO MANUFACTURER SPECIFICATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL FIELD SERVICE REPRESENTATIVE WENT ONSITE TO EVALUATE THE DEVICE. UPON INSPECTION, FOUND TUBING TO BE WEAK AND CRACKED/LEAKING. TECHNICIAN REPLACED TUBING. OPERATIONAL VERIFICATION PROCEDURE PERFORMED AND PASS. UNIT OPERATES TO MANUFACTURER SPECIFICATION. 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 THERE ARE NO VOLUMES AND THAT THE LOW PEAK PRESSURE ALARM WAS SOUNDING ON THE VELA VENTILATOR. 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
    1141594 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown