BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 9214028 · Received October 21, 2019

    Report

    Report Number
    2021710-2019-10931
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    September 23, 2019
    Report Date
    September 23, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4). THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT FOR INVESTIGATION. AN INVESTIGATION WAS PERFORMED AND THE ROOT CAUSE WAS UNDETERMINED. THE REPORTED PROBLEM WAS UNABLE TO BE CONFIRMED OR DUPLICATED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE COMPLAINT #: (B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. 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 · 1

    IT WAS REPORTED TO VYAIRE THAT THE AVEA VENTILATOR STARTED TO ALARM WITH SEVERAL ALARMS WHILE IN USE ON A PATIENT. THE CUSTOMER ADVISED THE PATIENT WAS PLACED ON ANOTHER VENTILATOR AND THERE WAS NO PATIENT HARM. CUSTOMER STATED HE PULLED THE EXH CORNER APART AND FOUND THE EXH FILTER, SENSOR AND THE SENSOR LINES GOING ALL THE WAY INTO THE GDE HAVE WATER IN THEM. CUSTOMER WAS ADVISED THE GDE WILL NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007935 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention