BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 10440110 · Received August 21, 2020

    Report

    Report Number
    2021710-2020-12397
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    July 24, 2020
    Report Date
    July 24, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION:B5 DEVICE EVALUATION: G3, G6, H2, H3, H6 AND H10. RESULT OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. THE VENTILATOR WAS POWERED IN VENTILATE MODE AND SERIES OF ALARM BECOME VISIBLE UPON START: XDCR FAULT, HIGH PIP, LOW VE, AND HIGH RATE WHILE AUTO-CYCLING. THE UNIT WAS ALSO POWERED IN SERVICE MODE AND LOG FILE SHOWS MULTIPLE XDCR FAULT. THIS IS A KNOWN ISSUE WHICH CAN BE REFERENCED WITH CAPA CA-2017-0206 AND SCAR PS-14-46. 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

    THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    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 WAS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE IN PATIENT USE THE VELA VENTILATOR ALARMED XDCR FAULT, HIGH RATE, HIGH PIP AND LOW VE. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901746 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1