BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 8337066 · Received February 13, 2019

    Report

    Report Number
    2021710-2019-09874
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 17, 2019
    Report Date
    January 17, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE VYAIRE SERVICE DEPARTMENT RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A FAILED CONTROL PCBA BOARD. THE UNIT HAS PASSED ALL TEST, CALIBRATIONS AND IS WORKING TO MANUFACTURE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THE DEVICE PASSED ALL TESTING AND MET ALL VYAIRE MANUFACTURER SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE AVEA VENTILATOR, THE USER INTERFACE MODULE (UIM) SCREEN DOES NOT RESPOND TO INPUT AND IS FROZEN. THE CUSTOMER STATED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128793 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA STD

    Patients

    Seq Age Sex Outcome Treatment
    1