BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 13981695 · Received April 1, 2022

    Report

    Report Number
    3000219639-2022-00017
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    January 30, 2022
    Report Date
    April 1, 2022
    Manufacturer
    SALTER LABS
    Product Code
    BYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENTS DESATURATED DURING USE. IFU RECOMMENDS NOT USE VAPETHERM WITH THE NON-REBREATHERS. RISK ANALYSIS NEEDS TO BE REVIEWED ABOUT VAPETHERM BEING USED WITH THE NON-REBREATHER MASKS. NEED TO MAKE SURE CUSTOMER IS AWARE THAT THEY SHOULD NOT BE USING THIS WITH THE NON-REBREATHERS.

    Additional Manufacturer Narrative · 0

    THE PATIENTS DESATURATED DURING USE. IFU RECOMMENDS NOT USE VAPETHERM WITH THE NON-REBREATHERS. RISK ANALYSIS NEEDS TO BE REVIEWED ABOUT VAPETHERM BEING USED WITH THE NON-REBREATHER MASKS. NEED TO MAKE SURE CUSTOMER IS AWARE THAT THEY SHOULD NOT BE USING THIS WITH THE NON-REBREATHERS COMPLAINT HISTORY REVIEWED. THERE IS ONE OTHER COMPLAINTS FOR THIS PRODUCT IN PREVIOUS 24MONTHS, HOWEVER, IT APPEARS TO BE A DUPLICATE AS IT IS THE SAME PRODUCT, LOT # AND CUSTOMER. SAMPLE TESTED WITH NON-HEATED AIR TO VERIFY FAILURE MODE. BAG PARTIALLY REMOVED FROM MASK ASSEMBLY AT 39.75LPM WITH OCCLUSION AT THE GROMMET. REASONABLE ASSUMPTION THAT HEATED AIR AND HIGH FLOW COULD FATIGUE ADHESIVE AND CAUSE BAG TO COME UNSEATED FROM GROMMET. CURRENT IFU SPECIFIES A MINIMUM FLOW RATE OF 5LPM BUT NO MAXIMUM. PENDING UPDATE TO IFU WILL CONTAIN A MAXIMUM FLOW RATE. RISK(RMA-20014A): R58: MASK BONDS LEAK CAUSING LOW OXYGEN DELIVERY DUE TO FATIGUE OF MASK COMPONENT BONDS - S=7 O=3 RPN=21. RPN < 25 THEREFORE RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    THE BAG IS POPPING OUT FROM UNDER THE GREEN TAPE HOLDING IT IN PLACE. THOUGHT TO POSSIBLY DUE TO PATIENTS BEING ON VAPOTHERM. THE PATIENTS INVOLVED IN THE INCIDENTS HAVE DESATURATED FROM THE EVENTS, BUT RECOVERED WHEN NEW NRB APPLIED. NOT AWARE OF ANY MAJOR ADVERSE OUTCOMES FROM EVENTS. 8 TOTAL EVENTS REPORTED INVOLVING 5 DIFFERENT PATIENTS.

    Description of Event or Problem · 0

    THE BAG IS POPPING OUT FROM UNDER THE GREEN TAPE HOLDING IT IN PLACE. THOUGHT TO POSSIBLY DUE TO PATIENTS BEING ON VAPOTHERM. THE PATIENTS INVOLVED IN THE INCIDENTS HAVE DESATURATED FROM THE EVENTS, BUT RECOVERED WHEN NEW NRB APPLIED. NOT AWARE OF ANY MAJOR ADVERSE OUTCOMES FROM EVENTS. 8 TOTAL EVENTS REPORTED INVOLVING 5 DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458063 SALTER LABS MASK, ADULT, OXYGEN, HIGH CONCENTRATION, NON-REBREATHING, SEE ORACLE FOR FULL DE BYG SALTER LABS 8140TG-7

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other