BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 18256616 · Received December 4, 2023

    Report

    Report Number
    2021710-2023-18473
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 4, 2023
    Manufacturer
    CBK
    Product Code
    CBK
    UDI-DI
    10846446001358
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4) H10: A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE AND TESTED THE UNIT. THE VENT WAS WORKING PROPERLY AND IS WITHIN OEM (ORIGINAL EQUIPMENT MANUFACTURER) SPECIFICATIONS. THE UNIT WAS HANDED BACK TO STAFF TO BE PLACED BACK IN SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT IS NOT DELIVERING TIDAL VOLUME INSPIRED (VTI) ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450805 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CBK VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown