BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT

    MDR report key: 17331012 · Received July 17, 2023

    Report

    Report Number
    8030673-2023-00336
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 16, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZE
    UDI-DI
    10190752157408
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION:(B)(4). H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : DEVICE NOT RETURNED YET.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AIRLIFE INFANT NON-HEATED CIRCUITS (6800-503) ARE DEFECTIVE. THE WATER TRAP OF THE SAID PRODUCTS, WAS HARDER TO REMOVE THAN USUAL .THE REPORTED INCIDENT DID NOT HAPPEN DURING PATIENT USE BUT ONE OF THE RESPIRATORY THERAPIST AT NICU DEPARTMENT HAD MINOR LACERATIONS WHEN THE WATER TRAP BROKE WHILE HE WAS OPENING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937889 AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE VYAIRE MEDICAL AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT 4170314 10190752157408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown