BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVEA VENTILATOR

    MDR report key: 14348215 · Received May 10, 2022

    Report

    Report Number
    2021710-2022-15931
    Event Type
    Death
    Date Received
    May 10, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 12, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    10846446066074
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SUSPECT DEVICE/COMPONENT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET. HOWEVER, THE CUSTOMER STATED THAT THE END USE HEARD AN ALARM AND THE UNIT HAS BEEN RUNNING FOR A FEW DAYS AND THAT HE HAS NOT BEEN ABLE TO REPLICATE THE REPORTED ISSUE. THE DEVICE WILL BE INVESTIGATED ONSITE. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS NOT ABLE TO CONFIRM THE ISSUE, AND A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ON-SITE. THE CUSTOMER STATED THAT THE UNIT WAS WORKING PROPERLY AND THAT HE NEEDED A VYAIRE SERVICE REPRESENTATIVE TO PERFORM CHECKS ON THE UNIT TO ENSURE THAT IT WAS WITHIN SPECIFICATIONS. THE UNIT PASSED THE OPERATIONAL VERIFICATION PROCEDURE (OVP) ACCORDING TO THE SERVICE MANUAL. THE UNIT MEETS FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR WOULD NOT READ ANY VOLUMES WHILE CONNECTED TO A PATIENT. FURTHERMORE, WHILE BEING REMOVED FROM THE VENTILATOR, THE PATIENT CODED AND DIED DUE TO A PRE-EXISTING CONDITION BUT WITH NO ALLEGATION WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644674 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. AVEA STANDARD 10846446066074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death