BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE ADULT OXYGEN MASK VINYL

    MDR report key: 12274253 · Received August 4, 2021

    Report

    Report Number
    8030673-2021-00183
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 7, 2021
    Report Date
    July 7, 2021
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CAT
    UDI-DI
    10190752116276
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION, HOWEVER, THE SAMPLE WAS NOT EVALUATED SINCE THEY ARE CONTAMINATED. THEREFORE, THE ROOT CAUSE WAS NOT DETERMINED AND NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME, SINCE THE INVESTIGATION IS STILL ONGOING. 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

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 001362 AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, 3 IN 1 MASK WITH 7' (2.1 M) CRUSH-RESISTANT TUBING AND U/CONNECT-IT ADAPTER HAS A HOLE NEAR THE TOP OF THE BAG WHERE IT CONNECTS TO THE FACE MASK. THE BAG NOT FILLING WITH OXYGEN NOR WAS IT ABLE TO PROVIDE ADEQUATE RELIEF WITH DESATURATION. A NEW NON-REBREATHER WAS GIVEN TO THE PATIENT, AND SHE WAS ABLE TO RECOVER WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170976 AIRLIFE ADULT OXYGEN MASK VINYL CANNULA, NASAL, OXYGEN CAT VYAIRE MEDICAL INC. AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, 3 IN 1 MASK WITH 7' (2.1 UNKNOWN 10190752116276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention