BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML.

    MDR report key: 18361414 · Received December 19, 2023

    Report

    Report Number
    3013421741-2023-00054
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 19, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BTT
    UDI-DI
    10190752141643
    PMA / PMN Number
    K853146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE UNAVAILABILITY OF PHOTOGRAPHS, SPECIFIC QUANTITIES OF THE AFFECTED MATERIAL, AND SAMPLES AVAILABLE FOR EVALUATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. THE RESULTS OF THE FUNCTIONAL TESTS, PIVOT OPENING, TIGHTNESS, THICKNESS MONITORING, BOTTLE SEAL DIAMETER AND THICKNESS MONITORING, BACKPRESSURE OPENING, AND STATISTICAL INSPECTIONS BY STAGE, AS WELL AS EACH OF THE REJECTIONS DUE TO DEFECTIVE ITEMS IDENTIFIED AND SEGREGATED DURING PRODUCT MANUFACTURING, ARE AVAILABLE. TEST RESULTS COMPLY WITH VALIDATED PARAMETERS AND PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING USE, THE HOSPITAL STAFF NOTICED THAT THE 002620 - HUMIDIFIER KIT 500ML 12/CS WAS EASILY DISENGAGED FROM THE OXYGEN GAUGE. THEY ALSO OBSERVED THAT IT CONSTANTLY ALARMS, AND THE PRESSURE IS BUILDING UP INSIDE THE BOTTLE, WHICH CAUSES IT TO EXPAND OR BLOAT. UPON INSPECTION, THEY NOTICED THAT THE OXYGEN PORT OPENING WAS TOO SMALL.THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106227 AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML. HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VYAIRE MEDICAL HUMIDIFIER KIT 500ML 12/CS TL2302015 10190752141643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown