BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM PF

    MDR report key: 12771170 · Received November 4, 2021

    Report

    Report Number
    MW5105158
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 3, 2021
    Manufacturer
    VAPOTHERM INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HFNC VAPOTHERM WAS SETUP AND PLACED ON PT STERILE WATER BAG INFLATED DURING USE EXCESS WATER FLOWED OUT OF CIRCUIT INTO PT NOSE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653671 VAPOTHERM PF HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM INC. 11070037 HFTL28637

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention STERILE WATER