BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN MASK (ADULT), HIGH CONCENTRATION NON-REBREATHER

    MDR report key: 13534143 · Received February 15, 2022

    Report

    Report Number
    13534143
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 30, 2022
    Report Date
    February 9, 2022
    Manufacturer
    SALTER LABS
    Product Code
    KGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RECENTLY HAVING MULTIPLE INCIDENTS WITH NRB (NON-REBREATHER) MASKS HAVING THE BAG POP OUT FROM UNDER THE GREEN TAPE HOLDING IT IN PLACE. THE BAG IS TYPICALLY INTACT/NOT TORN WHEN IT POPS OFF THE MASK. IT APPEARS THAT THE GREEN SECUREMENT TAPE IS FAILING. PATIENTS ARE TYPICALLY ON VAPOTHERM WHEN THIS HAPPENS, NOT SURE IF THIS IS AFFECTING THE INTEGRITY OF THE SECUREMENT TAPE. THE MASK INFORMATION HAS BEEN DISCARDED IN THE MAJORITY OF THE REPORTED EVENTS, BUT 3 LOT NUMBERS WERE IDENTIFIED (2 ON SAME PATIENT). LOT (10)201019, LOT (10)210927 ON THIS PATIENT. LOT (10)211206 ON ANOTHER PATIENT. 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
    1543933 OXYGEN MASK (ADULT), HIGH CONCENTRATION NON-REBREATHER MASK, OXYGEN, NON-REBREATHING KGB SALTER LABS 8140TG-7 201019

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA Male