BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 2462603 · Received February 7, 2012

    Report

    Report Number
    2462603
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    December 21, 2011
    Report Date
    February 7, 2012
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WATER BAG WAS CHANGED AND THE UNIT STOPPED WORKING. TROUBLESHOT EQUIPMENT - INSTRUCTION MANUAL INDICATED INTERNAL COMPONENT FAILURE. PATIENT WAS PLACED ON DIFFERENT UNIT. NO HARM CAME TO THE PATIENT. BIOMED TAGGED, REMOVED, AND WILL TEST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW HUMIDIFIER BTT VAPOTHERM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO