BEUDAMED
    FDA Adverse Event Death Summary report: N

    VELA VENTILATOR

    MDR report key: 17144680 · Received June 16, 2023

    Report

    Report Number
    2021710-2023-17828
    Event Type
    Death
    Date Received
    June 16, 2023
    Date of Event
    April 8, 2023
    Report Date
    June 16, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001358
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL FIELD SERVICE TECHNICIAN WENT ONSITE TO EVALUATE THE DEVICE. TECHNICIAN COULD NOT DUPLICATE THE PROBLEM. PERFORMED OWNER VERFICATION PROCESS AND PERFORMANCE CHECK, ALL PASSED. ALL WORK ACCOMPLISHED PER VELA SERVICE MANUAL REV.F. VENTILATOR IS OPERATIONAL AND MEETS MANUFACTURER SPECIFICATIONS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - 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 · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT CIRCUIT DISCONNECT OCCURRED DURING USE ON A PATIENT THAT CAUSE PATIENT DEATH AND NOT THE VENTILATOR ITSELF ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THAT THE NURSE RECONNECTED THE CIRCUIT AND HAD TO CALL CODE BLUE. THE PATIENT CODED AND THEN PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462188 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D