BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 6985593 · Received October 27, 2017

    Report

    Report Number
    2021710-2017-06876
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 2, 2017
    Report Date
    February 2, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUSPECT DEVICE/COMPONENT HAS BEEN RECEIVED BY VYAIRE. AN INVESTIGATION IS CURRENTLY PENDING. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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 DEFECTIVE O2 BLENDER.

    Additional Manufacturer Narrative · 1

    THE VYAIRE FAILURE ANALYSIS LAB 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 THE O2 BLENDER ASSEMBLY CANNOT BE BROUGHT WITHIN CALIBRATION. THE UNIT HAS PASSED ALL TEST, CALIBRATIONS AND IS WORKING TO MANUFACTURE SPECIFICATIONS. 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 DEFECTIVE O2 BLENDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE AVEA VENTILATOR, IT IS ALARMING HIGH FIO2. THE CUSTOMER STATED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762616 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC AVEA STD

    Patients

    Seq Age Sex Outcome Treatment
    1