BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 7148551 · Received December 27, 2017

    Report

    Report Number
    2021710-2017-07202
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 27, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 THAT WHILE USING THE AVEA VENTILATOR, THE USER INTERFACE MODULE (UIM) SCREEN STAYS DARK. THE CUSTOMER STATED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927689 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC AVEA STD

    Patients

    Seq Age Sex Outcome Treatment
    1