BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM

    MDR report key: 557625 · Received November 23, 2004

    Report

    Report Number
    1125759-2004-00002
    Event Type
    Other
    Date Received
    November 23, 2004
    Date of Event
    October 1, 2002
    Report Date
    November 23, 2004
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED PSEUDOMONAS AERUGINOSA CULTURED FROM FOUR PTS IN NICU. ALL HAD BEEN TREATED WITH RENTED VAPOTHERM UNITS, THOUGH THE UNITS USED FOR EACH PT COULD NOT BE IDENTIFIED. CULTURE SAMPLES WERE OBTAINED FROM SEVERAL POINTS ON TWO OF THE 6 UNITS. P. AERUGINOSA WAS IDENTIFIED IN ONE OF THE CULTURES. OTHER PATHOGENS, NOT FOUND IN THE PTS, WERE ALSO ISOLATED FROM THE CULTURE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM RESPIRATORY THERAPY DEVICE BTT VAPOTHERM, INC. 2000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY Other