BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 11303045 · Received February 9, 2021

    Report

    Report Number
    2021710-2021-13325
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    December 24, 2020
    Report Date
    October 22, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    70846446001442
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4) RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECTED DEVICE AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED THROUGH THE EVENT LOGS AND DETERMINED TO BE DUE TO A FAILED SOLENOID. THIS IS A KNOWN ISSUE WHICH CAN BE REFERENCED WITH CO# 101543. 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 FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VELA VENTILATOR EXPERIENCED TRANSDUCER FAULT. 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
    200737 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 70846446001442

    Patients

    Seq Age Sex Outcome Treatment
    1