BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿ HYGROSCOPIC CONDENSER HUMIDFIER

    MDR report key: 17880036 · Received October 5, 2023

    Report

    Report Number
    8030673-2023-00352
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 5, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BYD
    UDI-DI
    10190752147126
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: BASED ON THE INVESTIGATION AND PER ONE PICTURE SENT BY THE COSTUMER OF FG 5704EU WE CANNOT CONFIRM THE REPORTED DEFECT SINCE THE IFU (INSTRUCTION FOR USE) STATES THE FOLLOWING: ''DUE TO THE HCH'S HIGH EFFICIENCY, YOU MAY SEE CONDENSATE IN THE POLYBAG. THIS IS NORMAL OCCURRENCE DUE TO THE HIGH EFFICIENCY OF THE HCH PRODUCT.'' THIS MEANS THAT CONDENSATION INSIDE THE BAG OR THE PRESENCE OF WATER DROPLETS IS EXPECTED IN THIS PRODUCT. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: DEVICE HISTORY RECORD FOR FG 5704EU WITH LOT NUMBER 0004229546 AND WAS REVIEWED AND NO ISSUES WERE FOUND. BASED ON THE INVESTIGATION AND PER ONE CLOSED PHYSICAL SAMPLE SENT BY THE COSTUMER OF FG 5704EU WITH LOT NUMBER 0004229546 WE CANNOT CONFIRM THE REPORTED DEFECT SINCE THE IFU (INSTRUCTION FOR USE) STATES THE FOLLOWING: ''DUE TO THE HCH'S HIGH EFFICIENCY, YOU MAY SEE CONDENSATE IN THE POLYBAG. THIS IS NORMAL OCCURRENCE DUE TO THE HIGH EFFICIENCY OF THE HCH PRODUCT.'' THIS MEANS THAT CONDENSATION INSIDE THE BAG OR THE PRESENCE OF WATER DROPLETS IS EXPECTED IN THIS PRODUCT AND DOES NOT COMPROMISE THE FUNCTIONALITY OF THE PRODUCT. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER ¿ AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT 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 5704EU HME FILTERS HAVE CONDENSATION INSIDE THE BAGS AND WAS USED ON A PATIENT. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246780 AIRLIFE¿ HYGROSCOPIC CONDENSER HUMIDFIER CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) BYD VYAIRE MEDICAL HME NEONATAL 50/CS 0004229546 10190752147126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown