BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER THE CHIN STYLE, HIGH CONCENTRATION REBRE

    MDR report key: 18360454 · Received December 19, 2023

    Report

    Report Number
    8030673-2023-00366
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 19, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CAT
    UDI-DI
    10190752116344
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION AND SINCE THE CUSTOMER SENT PICTURES AND NO PHYSICAL SAMPLE OF THE FG PART NUMBER 001205 WITH LOT NUMBER 0004091561 FOR THE INVESTIGATION, WE CANNOT CONFIRM THE REPORTED DEFECT SINCE IN THE PICTURES SENT BY THE CUSTOMER, WE CAN APPRECIATE THAT THE OXYGEN BAG DOES NOT INFLATE WHEN IT IS CONNECTED TO AN OXYGEN FLOW. HOWEVER, THIS IS NORMAL FOR PART NUMBER 001205 BECAUSE THE OXYGEN BAG ONLY INFLATES WHEN IT IS BEING USED BY THE PATIENT, AND THIS MODEL, UNLIKE OTHERS, DOES NOT HAVE GASKETS. IN ADDITION, (B)(4). WAS REVIEWED, AND CONTROLS WERE IMPLEMENTED FOR THIS TYPE OF DEFECT. BASED ON THE ABOVE REPORTED DEFECT, IT WAS NOT CONFIRMED, AND THE ROOT CAUSE WAS NOT ESTABLISHED. ADDITIONAL INFORMATION: THE MASK MODEL WAS CHANGED. OXYGENATION HAS BEEN ADAPTED WITH ANOTHER DEVICE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - THE CUSTOMER DID NOT SEND A PICTURE OR PHYSICAL SAMPLE FOR INVESTIGATION. WE REQUIRE THE PHYSICAL SAMPLE AND/OR PICTURES AS EVIDENCE TO PERFORM A BETTER INVESTIGATION AND DETERMINE THE CAUSE OF THE REPORTED DEFECT THE DEVICE HISTORY RECORD OF THE FG PART NUMBER 001205 WITH LOT NUMBER 0004091561 WAS REVIEWED AND NO ISSUES WERE FOUND DURING ITS MANUFACTURING.THEREFORE, THE REPORTED DEFECT WAS NOT CONFIRMED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THAT FOR THE MANAGEMENT OF PATIENTS WITH OAP, THEY LOGICALLY USED THE AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER THE CHIN STYLE, HIGH CONCENTRATION REBREATHER MASK (NO VAVLES) WITH 7 FEET (2.1 M) CRUSH RESISTANT OXYGEN TUBING WITH 100% FIO2 (FRACTION OF INSPIRED OXYGEN). HOWEVER, FOR SOME TIME NOW, THEY HAVE BEEN EXPERIENCING A PROBLEM WITH ITS IMPLEMENTATION. DESPITE HIGH OXYGEN FLOW, SUITABLE PLACEMENT ON THE FACE, THE RESERVOIR OF THESE MASKS REMAINS FLAT. NO SUFFICIENT FILLING IS POSSIBLE. THIS MASK IS INEFFECTIVE DESPITE THE FACT THAT THE AIR INTAKES ON BOTH SIDES OF THE MASKS ARE SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049598 AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER THE CHIN STYLE, HIGH CONCENTRATION REBRE CANNULA, NASAL, OXYGEN CAT VYAIRE MEDICAL MASK OXYGEN REBR W/7 TBG NO VALVE 50/CS 0004091561 10190752116344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown