BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 7566277 · Received June 4, 2018

    Report

    Report Number
    2021710-2018-07929
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    July 13, 2016
    Report Date
    June 4, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT MAIN PRINTED CIRCUIT BOARD ASSEMBLY FOR INVESTIGATION. AN EVALUATION OF THE COMPONENT COULD BE CONFIRMED AND DUPLICATED. THE R608 IS FAULTY. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE TESTING THE VELA VENTILATOR; THE DEVICE DISPLAYS VENTILATOR INOPERABLE ALARMS. THE EVENTS LOG DISPLAYS POST DAC OR ADC ERRORS AND 24 VOLTS SUPPLY TOO LOW. THE CUSTOMER DETERMINED THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407079 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1