BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH VELOCITY HI-VI

    MDR report key: 19713036 · Received July 9, 2024

    Report

    Report Number
    MW5157143
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 5, 2024
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RESPIRATORY THERAPIST CALLED TO BEDSIDE DUE TO VAPOTHERM FLOW STOPPED, ERROR CODE 54 FLASHING AND BEEPING. PATIENT PLACED ON NON-REBREATHER OXYGEN MASK. VAPOTHERM PULLED FROM SERVICE AND BIOMED ORDER PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348201 HIGH VELOCITY HI-VI HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female