BEUDAMED
    FDA Adverse Event Summary report: N

    VAPOTHERM PRECISION FLOW

    MDR report key: 3811975 · Received May 9, 2014

    Report

    Report Number
    3811975
    Date Received
    May 9, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 3, 2014
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE BIOMEDICAL ENGINEERING PERFORMANCE VERIFICATION OF THE PRECISION FLOW UNIT, THE DISPLAY ALWAYS READS HIGH FLOW DWP CIRCUIT INSTALLED REGARDLESS OF WHETHER IT HAS A HIGH FLOW, LOW FLOW OR NO DWP CIRCUIT AT ALL. THIS MAY RESULT IN INJURY TO A NEONATAL PATIENT RECEIVING A FLOW THAT IS TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281303 VAPOTHERM PRECISION FLOW HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *