BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 7620629 · Received June 20, 2018

    Report

    Report Number
    2021710-2018-07998
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 20, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. FIELD SERVICE REP EVALUATION: THE FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO EVALUATE THE SUSPECT DEVICE. THE FSE REPLACED THE UIM COMPONENT ON THE SUSPECT VENTILATOR DEVICE AND PERFORMED THE OPERATIONAL VERIFICATION OF THE DEVICE, WHICH MET MANUFACTURE SPECIFICATIONS . AT THIS TIME, VYAIRE MEDICAL FAILURE ANALYSIS LABORATORY HAS NOT RECEIVED THE SUSPECT UIM COMPONENT FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT BLANK USER INTERFACE MODULE (UIM) DISPLAY ON THIS VENTILATOR DEVICE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460984 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1