BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM

    MDR report key: 666227 · Received December 2, 2005

    Report

    Report Number
    MW1037339
    Event Type
    Injury
    Date Received
    December 2, 2005
    Date of Event
    November 28, 2005
    Report Date
    December 2, 2005
    Manufacturer
    VAPOTHERM INC
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECENTLY VAPOTHERM, A HIGH FLOW NASAL CANNULA OXYGEN DELIVERY DEVICE, HAS BEEN REPORTED TO GROW RALSTONIA SPECIES. AFTER IMPLEMENTING THE NEW CLEANING RECOMMENDATIONS FROM VAPOTHERM - PUBLISHED 11/2005-, RALSTONIA SPP. WAS CULTURED FROM 7 OF 10 IN-USE VAPOTHERM UNITS. LENGTH OF TIME IN USE RANGED FROM 6-30 DAYS. ALL UNITS HAD BEEN CLEANED USING THE NEW RECOMMENDATIONS. ALL VAPOTHERM UNITS HAVE BEEN DISCONTINUED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM VAPOTHERM BTT VAPOTHERM INC 2000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability