BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDIFIER KIT 500ML 12/CS

    MDR report key: 12629035 · Received October 13, 2021

    Report

    Report Number
    3013421741-2021-00012
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 2, 2021
    Product Code
    BTT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE DEFECTIVE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE ISSUES ON 002620-A HUMIDIFIER KIT 500ML 12/CS. WHEN THE FLOW IS SET TO >4LPM, THE HUMIDIFIER SQUEALS DUE TO BACKPRESSURE. THE FRONT PART WHERE YOU TWIST OFF THE ADAPTER TO CONNECT TO THE PATIENT TUBING DOES NOT CREATE AN ORIFICE FOR FLOW TO PASS THROUGH, OR IS TOO SMALL, RESULTING IN INCREASED BACK PRESSURE FROM TUBING OBSTRUCTION AND CREATING A FOUNTAIN OF WATER, DOUSING CONTENTS TO THE STAFF, PATIENTS, AND ROOM. THERE WAS NO CLEAR INFORMATION ON PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527126 HUMIDIFIER KIT 500ML 12/CS HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT HUMIDIFIER KIT 500ML 12/CS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1