BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 8953762 · Received September 2, 2019

    Report

    Report Number
    2021710-2019-10735
    Event Type
    Injury
    Date Received
    September 2, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 6, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001631
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE COMPLAINT #: (B)(4). THE VENTILATOR WAS TESTED AND THE ALARM WAS REPRODUCED. THE MAIN PCB WAS REPLACED AND THE ALARM STOPPED. WE ARE CURRENTLY WAITING FOR THE COMPONENT TO ARRIVE AT THE MANUFACTURING SITE FOR EVALUATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE COMPLAINT #: (B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. 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

    IT WAS REPORTED TO VYAIRE THAT THE VELA VENTILATOR EXPERIENCED A CIRCUIT OCCLUSION ALARM WHILE IN USE ON A PATIENT. THE PATIENT WAS MOVED TO ANOTHER VENTILATOR. THE CUSTOMER ADVISED THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747260 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention