BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 19262137 · Received May 7, 2024

    Report

    Report Number
    2021710-2024-19077
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 7, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE INDENTIFICATION: (B)(4). H3: 81 OTHER ¿ CURRENTLY, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A ROOT CAUSE HAS NOT BEEN DETERMINED. THE ISSUE WAS RESOLVED BY TROUBLESHOOTING WAS REQUESTED BY THE CUSTOMER AND THE ISSUE WAS RESOLVED BY VYAIRE'S TECHNICAL SUPPORT TEAM. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : TROUBLESHOOTING WITH VYAIRE MEDICAL TECH SUPPORT RESOLVED THE ISSUE

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THE CUSTOMER IS REQUESTING TROUBLESHOOTING FOR FIO2 AND VTE ISSUES. LOW FIO2 ALARM APPEARED. UNIT WAS ON A PATIENT WITH NO HARM, SWAPPED OUT WITH ANOTHER AVEA VENTILATOR. NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668859 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA STANDARD VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention