BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM

    MDR report key: 1329060 · Received February 26, 2009

    Report

    Report Number
    MW5010121
    Event Type
    Injury
    Date Received
    February 26, 2009
    Date of Event
    February 26, 2009
    Report Date
    February 26, 2009
    Manufacturer
    VAPOTHERM INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HIGH FLOW O2 THERAPY EQUIPMENT FAILED TO ALARM WHEN FLOW TO PT CIRCUIT STOPPED. DISPLAY AND ALARM CONDITION INDICATED NORMAL BUT NO FLOW COULD BE MEASURED AT PT CIRCUIT. STAFF DISCOVERED THIS PRIOR TO PT USE. ONE OTHER DEVICE ON A PT WHICH "DESATURATED" BUT COULD NOT BE REPRODUCED. THE AREA THESE WERE IN USE WAS A NEONATE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM HIGH FLOW O2 THERAPY BTT VAPOTHERM INC. PRECISION FLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability