BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION FLOW HI-VNI

    MDR report key: 12480820 · Received September 15, 2021

    Report

    Report Number
    MW5103975
    Event Type
    Death
    Date Received
    September 15, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 14, 2021
    Manufacturer
    VAPOTHERM INC.
    Product Code
    QAV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON NON-REBREATHER MASK AT 100% 02 VAPOTHERM HI-FLOW NASAL CANNULA. AT APPROXIMATELY 0030 THE VAPOTHERM STARTED ALARMING, SHOWING TEMP SETTING AS LOW. NURSE CONTACTED THE RESPIRATORY THERAPIST THAT THERE WAS AN ISSUE WITH THE VAPOTHERM. THERAPIST NOTED ON ARRIVAL THAT THERE WAS A HEATER MALFUNCTION, AT THIS TIME THE PATIENT WAS AWAKE AND CONVERSING WITH NURSE. AT 0052 SUDDENLY THE PATIENT BECAME UNRESPONSIVE, NO PULSE, NO RESPIRATIONS. CODE BLUE WAS CALLED, PATIENT WAS INTUBATED, REGAINED ROSC, WAS CODED TWO MORE OCCASIONS AND EVENTUALLY EXPIRED AT 0126. PATIENT PRESENTED WITH WORSENING DIFFICULT BREATHING, SHORTNESS OF BREATH, COVID-19 POSITIVE 8 DAYS PRIOR TO ARRIVAL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375607 PRECISION FLOW HI-VNI HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death