BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 10194392 · Received June 25, 2020

    Report

    Report Number
    10194392
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    October 21, 2019
    Report Date
    October 29, 2019
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CALLED TO PATIENTS ROOM BY RN THAT VAPOTHERM MACHINE NOT WORKING. WHEN ARRIVED I NOTICED THAT MACHINE WAS NOT WORKING AND THAT ALL LIGHTS WERE OFF. TRIED TO TROUBLE SHOOT MACHINE BUT IT WOULD NOT START. CHANGED MACHINE OUT. PT STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660975 PRECISION FLOW HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM, INC. PF-UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1