BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULA, NASAL, OXYGEN

    MDR report key: 19252576 · Received May 3, 2024

    Report

    Report Number
    MW5154583
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 27, 2024
    Report Date
    May 1, 2024
    Manufacturer
    VAPOTHERM INC
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE THERAPIST HEARD THE DEVICE ALARMING AND NOTICED DASHES OVER THE FRACTION OF INSPIRED OXYGEN DISPLAY AND NO FLOW COMING OUT OF THE NASAL CANNULA. THE PATIENT WAS IMMEDIATELY PLACED ON A NON-REBREATHER MASK FOR THE TRANSPORT WHICH HE TOLERATED WELL. THERE WAS NO PATIENT HARM DUE TO THE MALFUNCTION. THE BATTERY WAS FULLY CHARGED, AND THE OXYGEN TANKS WERE FULL FOR THE TRANSPORT. NO USER ERROR IDENTIFIED. CLINICAL ENGINEERING EVALUATED VAPOTHERM AND FOUND IT TO BE FUNCTIONING PROPERLY. PFPC00014543-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669487 CANNULA, NASAL, OXYGEN CANNULA, NASAL, OXYGEN CAT VAPOTHERM INC PFPC00014543-E

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention