BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 10498374 · Received September 6, 2020

    Report

    Report Number
    2021710-2020-12492
    Event Type
    Malfunction
    Date Received
    September 6, 2020
    Date of Event
    August 27, 2020
    Report Date
    August 27, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446000368
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). THE CUSTOMER REPORTED THE DEVICE PASSED THE EXTENDED SELF TEST THEN PED AND NEO TESTINGS. THE ADULT TESTS ON PG 5-16 OF THE SVC MNL SHOWS THE FLOW SHOULD BE 30, IT IS DOWN IN THE LOW 20'S. WHEN CUSTOMER CHECKED THE VOLUMES THE ACTUAL SETTING IS 500 ML'S AND THE VTI ON VENT TESTER SHOWS TO BE .42 THE DEVICE MONITORED VALUE IS .46. THE CUSTOMER ALSO REPORTED THAT HE LOOKED AT TRANSDUCERS AT ZERO AND ALL WERE SPOT ON. HE TRIED A DIFFERENT FLOW SENSOR BUT DID NOT HAVE A KNOWN GOOD SENSOR AND IT AUTO CYCLED. THE CUSTOMER PUT FIRST SENSOR BACK ON AND AUTO CYCLING STOPPED. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. 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

    THE CUSTOMER REPORTED THAT AN AVEA VENTILATOR TIDAL VOLUME INSPIRATORY (VTI), TIDAL VOLUME EXPIRATORY (VTE) WAS LOW AND THE DEVICE HAS AN AUTO-CYCLED ISSUES. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962607 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA 10846446000368

    Patients

    Seq Age Sex Outcome Treatment
    1