BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 9257521 · Received October 30, 2019

    Report

    Report Number
    2021710-2019-10969
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    October 2, 2019
    Report Date
    February 22, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT # (B)(4). RESULTS OF INVESTIGATION: A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE AND COULD NOT DUPLICATE THE REPORTED PROBLEM. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SUSPECT DEVICE. ONCE EVALUATED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE I-TIME WAS INCORRECT ON THE VENTILATOR. THE CUSTOMER BELIEVED THE VENTILATOR WAS AUTO-CYCLING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049575 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA STD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention