BEUDAMED
    FDA Adverse Event Other Summary report: N

    2000I

    MDR report key: 670152 · Received January 23, 2006

    Report

    Report Number
    1125759-2006-00001
    Event Type
    Other
    Date Received
    January 23, 2006
    Date of Event
    December 13, 2005
    Report Date
    January 19, 2006
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE PT WAS IDENTIFIED WITH RALSTONIA ISOLATED FROM TRACHEAL ASPIRATE. THE PT WAS ADMITTED FOR HEART TRANSPLANT. PT HAS TREATED WITH VAPOTHERM PRE-TRANSPLANT. PT WAS TREATED WITH BIPAP AND MECHANICAL VENTILATION. THERE WAS NO INDICATION OF ADVERSE EVENT. THE VAPOTHERM WAS NOT CULTURED. PT WAS SUBSEQUENTLY DISCHARGED. ONE CYSTIC FIBROSIS PT CULTURED POSITIVE FOR RALSTONIA IN 2005. THIS PT WAS NOT TREATED BY A VAPOTHERM DEVICE. A DIALYSIS PT CULTURED POSITIVE FOR RALSTONIA 5 DAYS BEFORE THE TRANSPLANT PT. THE DIALYSIS PT WAS NOT IN PROXIMITY TO THE TRANSPLANT PT. THIS PT WAS NOT TREATED BY A VAPOTHERM DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR