BEUDAMED
    FDA Adverse Event Death Summary report: N

    VAPOTHERM 2000I

    MDR report key: 664243 · Received January 11, 2006

    Report

    Report Number
    1125759-2005-00006
    Event Type
    Death
    Date Received
    January 11, 2006
    Date of Event
    July 2, 2005
    Report Date
    January 11, 2006
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN JULY 2005 A RESPIRATORY THERAPIST ALLEGED A BABY DIED OF "PSEUD." (PSEUDOMONAS OUTBREAK). IN EMAIL, JULY 2005, ON NICU-NET WRITES ASKING IF THERE HAVE BEEN ANY POSITIVE ASSOCIATION OF PSEUDOMONAS OR OTHER "WATER BUGS" WHEN USING VAPOTHERM. SHE POINTS OUT IN HER EMAIL THAT THE HOSPITAL HAS HAD A RUN OF PSEUDOMONAS - NOT ISOLATED TO VAPOTHERM. BUT, WHEN THEY STOPPED USING VAPOTHERM THEY HAD NO FURTHER CASES. THE HOSPITAL HAD BEEN RENTING VAPOTHERM UNITS FOR APPROXIMATELY ONE YEAR WHEN THESE EVENTS WERE POSTED ON EMAIL OR THE INTERNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM 2000I HUMIDIFIER (BTT) BTT VAPOTHERM, INC. 2000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| O