BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPORTHEM

    MDR report key: 670445 · Received January 31, 2006

    Report

    Report Number
    1125759-2006-00003
    Event Type
    Other
    Date Received
    January 31, 2006
    Date of Event
    January 5, 2006
    Report Date
    January 30, 2006
    Manufacturer
    VAPOTHERM INC
    Product Code
    BTT
    Removal / Correction Number
    Z-0360-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INCOMING CALL TO VAPOTHERM IN 2006 THAT HOSPITAL REPORTED A POSITIVE COLONIZATION OF RALSTONIA SSP. CULTURE WAS OBTAINED VIA TRACHEAL ASPIRATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other