BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE PEDIATRIC OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, MEDIUM CONCENTRATION

    MDR report key: 16921956 · Received May 12, 2023

    Report

    Report Number
    8030673-2023-00319
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    March 22, 2023
    Report Date
    May 12, 2023
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CAT
    UDI-DI
    10190752116542
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: G3, G6, H2, H3, H6 AND H10 BASED ON THE INVESTIGATION CARRIED OUT AND PER PICTURE AND PHYSICAL SAMPLE RECEIVED, REPORTED DEFECT IS CONFIRMED (BUG INSIDE THE TUBE). HOWEVER, PROPER PEST CONTROLS WERE ESTABLISHED INDICATING A MONTHLY FUMIGATION OF EXTERNAL AND INTERNAL INSTALLATION OF VYAIRE'S PLANT. FUMIGATION CERTIFICATES FROM NOV 2019 AND DEC 2019 WERE REVIEWED, AND NO ANOMALIES WERE FOUND DURING THAT PERIOD OF TIME. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO ISSUES WERE FOUND. THEREFORE, THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT PRIOR TO PLACING 001262 - MASK OXYGEN UNDERCHIN PED 50/CS ON THE PATIENT, STAFF IDENTIFIED A BUG WITH SOME DEBRIS IN THE TUBING. THE CUSTOMER CONFIRMED THAT THE EVENT OCCURRED PRE-OPERATIVELY, AND NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309936 AIRLIFE PEDIATRIC OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, MEDIUM CONCENTRATION CANNULA, NASAL, OXYGEN CAT VYAIRE MEDICAL INC. MASK OXYGEN UNDERCHIN PED 50/CS 0004123269 10190752116542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown