BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML

    MDR report key: 11646024 · Received April 9, 2021

    Report

    Report Number
    3007502289-2021-00003
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 17, 2021
    Product Code
    BTT
    UDI-DI
    10885403070983
    PMA / PMN Number
    K853146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SEALING AND CONDITIONING SECTIONS OF THE DEVICE WERE REVIEWED TO IDENTIFY THE DEFECTS RELATED TO THE REPORTED ISSUE. HOWEVER, THE DHR (DEVICE HISTORY RECORD) REVIEW DID NOT IDENTIFY ANY DEVIATIONS, VALIDATED MANUFACTURING PROCESS PARAMETERS, AND SPECIFICATIONS OF RAW MATERIALS AND COMPONENTS THAT WERE USED DURING PRODUCTION THAT COULD RESULT IN THE REPORTED FAILURE. 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 THE 002620 AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML BLEW UP AND FAILED WHILE CONNECTED TO A PATIENT. 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
    543230 AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML HUMIDIFIER NEBULIZER BTT AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML TL2006043 10885403070983

    Patients

    Seq Age Sex Outcome Treatment
    1