BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 9598330 · Received January 16, 2020

    Report

    Report Number
    2021710-2020-11286
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    December 18, 2019
    Report Date
    February 26, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT NUMBER #: (B)(4). RESULTS OF INVESTIGATION: A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE AND VERIFIED THE REPORTED PROBLEM. FSR REPLACED THE FRONT DISPLAY. DEVICE WAS TESTED AND CONFIRMED TO BE FUNCTIONAL. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR'S SCREEN FROZE UP WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THAT THERE WAS A HIGH PITCHED ALARM THAT OCCURRED. THERE WAS NO REPORT OF ANY PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57790 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention