BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIFLOW NASAL CANNULA MACHINE

    MDR report key: 14282655 · Received May 3, 2022

    Report

    Report Number
    MW5109501
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 29, 2022
    Manufacturer
    VAPOTHERM INC.
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HIFLOW NASAL CANNULA 100% OXYGEN (40L/MIN) - MACHINE SCREEN DISPLAYED AN ERROR MESSAGE (SCREEN WAS BLACK, SHOWING ONLY THE CAUTION SYMBOL) WITH NO OXYGEN BEING DELIVERED TO PATIENT. PATIENT HAD RESPIRATORY ARREST (RESUSCITATED). A VAPOTHERM REP CAME TO THE HOSPITAL TO TEST THE DEVICE BUT COULD NOT REPLICATE THE ERROR. DEVICE WAS REMOVED FROM SERVICE, TO BE RETURNED TO MANUFACTURER ONCE REPLACEMENT OBTAINED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378967 HIFLOW NASAL CANNULA MACHINE HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| L