BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 9618512 · Received January 22, 2020

    Report

    Report Number
    2021710-2020-11298
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 27, 2019
    Report Date
    December 27, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001303
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT NUMBER (B)(4). ADDITIONAL INFORMATION: D9, G2, G3, G6, H2, H3, H6, H10. THE SAMPLE WAS RETURNED FOR EVALUATION. THE VYAIRE MEDICAL FAILURE ANALYSIS TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED ISSUE. CAUSE WAS IDENTIFIED AS SOLENOID FAILURE. THE ROOT CAUSE IS BEING INVESTIGATED UNDER CO# 101543.

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE VELA VENTILATOR ALARMED TRANSDUCER FAULTS AND VENTILATOR INOPERABLE (INOP). THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE. .THE REPORTED ISSUE OCCURRED IMMEDIATELY WHEN THE DEVICE WAS POWERED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81232 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001303

    Patients

    Seq Age Sex Outcome Treatment
    1