BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL CIRCUIT ADULT HTD VYAIRE 1 LIMB 8FT

    MDR report key: 24757987 · Received April 1, 2026

    Report

    Report Number
    MW5186269
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 27, 2026
    Manufacturer
    VYAIRE MEDICAL/SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AFTER 3 WEEKS OF USE, VYAIRE MEDICAL CIRCUIT ADULT HTD VYAIRE 1 LIMB 8FT (ITEM ID 4681-504) MELTED AT PART OF CIRCUIT THAT IS CLOSER TO THE MASK. NO HARM OCCURRED AND PRODUCT WAS EXCHANGED. PRODUCT WAS DISCARDED BY CAREGIVER, UNABLE TO OBTAIN LOT NUMBER PRIOR TO DISCARDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625020 VYAIRE MEDICAL CIRCUIT ADULT HTD VYAIRE 1 LIMB 8FT HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE VYAIRE MEDICAL/SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male CONCENTRATOR O2 STAT MILLENIUM 10LPM| HUMIDIFIER HEATED VENT F&P MR850| MASK NEB PARI LC ELONGATED ADULT| VENTILATOR TRILOGY 100