BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 7602386 · Received June 14, 2018

    Report

    Report Number
    2021710-2018-07970
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 14, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE CUSTOMER REPORTED THE SUSPECTED MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) IS AVAILABLE FOR ANALYSIS AND A RETURN GOOD AUTHORIZATION HAS BEEN ISSUED. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECTED MAIN PCBA FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE VELA VENTILATOR; THE DEVICE DISPLAYS VENTILATOR INOPERABLE, MOTOR FAULT, LOW MINUTE VENTILATION, AND LOW PEAK INSPIRATORY PRESSURE ALARMS. THE CUSTOMER PERFORMED TROUBLESHOOTING AND REPORTED POST DAC/ADC ERRORS IN THE EVENTS LOG. 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
    443776 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1