BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH FREQUENCY NASAL CANNULA

    MDR report key: 16185795 · Received January 13, 2023

    Report

    Report Number
    MW5114339
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    January 12, 2023
    Report Date
    January 12, 2023
    Manufacturer
    VAPOTHERM INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT IS A 78-YEAR-OLD MALE. PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2023 FOR SOB AND CHEST PAIN. PER PATIENT'S MEDICAL RECORD, HAS A HISTORY OF STOMACH CA AND CAD. PATIENT WAS PLACED ON HFNC ON (B)(6) 2023 FOR INCREASING SOB, 40LPM, 100% FIO2. ON (B)(6) 2023 ~0600, PATIENT NOTIFIED NURSING STAFF AND RT THAT VAPOTHERM MACHINE SHUT OFF WHILE PATIENT WAS USING MACHINE. VAPOTHERM WAS REPLACED WITH NEW MACHINE AND PATIENT WAS PLACED BACK ON PREVIOUS SETTINGS WITH NO COMPLICATIONS. VAPOTHERM MACHINE WAS TAGGED, REMOVED FROM SERVICE, AND BROUGHT TO BIOMED FOR INVESTIGATION. PATIENT REMAINS IN STABLE CONDITION SPO2 92%, HR 59, RR 16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16227 HIGH FREQUENCY NASAL CANNULA CANNULA, NASAL, OXYGEN CAT VAPOTHERM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention