BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM LOW FLOW CARTRIDGES

    MDR report key: 22749346 · Received August 8, 2025

    Report

    Report Number
    MW5174238
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 1, 2025
    Manufacturer
    VAPOTHERM INC.
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VAPOTHERM LOW FLOW CARTRIDGES ALL PACKAGED AS LOW FLOW WERE MISLABELED BY THE MANUFACTURER AND WERE HIGH FLOW UNITS. SPECIFIC LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007150 VAPOTHERM LOW FLOW CARTRIDGES HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM INC. LF F055462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown