BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 7053146 · Received November 22, 2017

    Report

    Report Number
    2021710-2017-07015
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 30, 2017
    Report Date
    February 6, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE VYAIRE MEDICAL FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT, A VELA MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), AND EVALUATED THE COMPONENT. AN EVALUATION OF THE COMPONENT DUPLICATED THE REPORTED ISSUE AND ISOLATED THE ISSUE TO SOLENOID FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: A VYAIRE MEDICAL FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE. THE FSR REPLACED THE MAIN BOARD AND THE REPORTED ISSUE WAS RESOLVED THE FSR PERFORMED THE OPERATIONAL VERIFICATION PROCEDURE (OVP) AND THE DEVICE MEETS MANUFACTURER'S SPECIFICATIONS. THE VYAIRE MEDICAL FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT, A VELA MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), FOR EVALUATION. UPON COMPLETION OF THE COMPONENT EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED "VENT INOP", "CIRCUIT DISCONNECT", AND "XDCR FAULT" (TRANSDUCER FAULT). THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833343 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1