BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA II VENTILATOR

    MDR report key: 14016179 · Received April 5, 2022

    Report

    Report Number
    2021710-2022-15869
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    July 7, 2021
    Report Date
    April 2, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446066074
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). VYAIRE MEDICAL WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. ISOLATED TO EPM TO PDT CABLE ASSEMBLY BEING INCORRECTLY ROUTED CAUSING FRICTION WITH MACHINED COMPRESSOR HOUSING EXPOSING CABLE 24 (PIN 24) WIRE CREATING AN ELECTRICAL SHORT. AS A RESOLUTION MOVE TO SERVICE DEPARTMENT TO HAVE THE EPM TO PDT CABLE ASSEMBLY AND DRIVER TRANSTN PCBA W/ HARNESS REPLACED AND DISPOSED. 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 · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR FAIL ON INSTALL. ON COMPRESSOR TEST WHEN DISCONNECTING FROM AIR IS REQUIRED THE UNIT GOES INOP AND THE COMPRESSOR NEVER TURNS ON. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT ISSUE OCCURRED DURING INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342820 AVEA II VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA II 10846446066074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown