BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM

    MDR report key: 694386 · Received March 28, 2006

    Report

    Report Number
    1125759-2006-00009
    Event Type
    Other
    Date Received
    March 28, 2006
    Date of Event
    December 13, 2005
    Report Date
    March 22, 2006
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Removal / Correction Number
    Z-0360-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM RECEIVED A REPORT FROM THE FDA REGARDING BUFFALO CHILDREN'S HOSPITAL. THE LETTER DESCRIBES AN INTUBATED PATIENT WHO HAD POSITIVE CULTURES FOR RALSTONIA. SIX OF THEIR VAPOTHERM UNITS WERE CULTURED BY THE HOSPITAL LAB FOR DISINFECTION. CULTURES WERE TAKEN FROM THE WATER SIDE OF THE MACHINE. THE REPORTER STATED THAT SAMPLES WERE SENT TO THE CDC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other