BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM 2000I

    MDR report key: 682596 · Received March 6, 2006

    Report

    Report Number
    1125759-2006-00005
    Event Type
    Other
    Date Received
    March 6, 2006
    Date of Event
    January 31, 2006
    Report Date
    February 27, 2006
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTER, INFECTION CONTROL PROFESSIONAL TELEPHONED VAPOTHERM TO REPORT A CASE OF RALSTONIA BACTERIA TAKEN FROM A TRACH CULTURE. THE CALL WAS RECEIVED IN FEB 2006. REPORTER REPORTED POSITIVE CULTURES FROM THE PATIENT'S TRACH TUBE IN JAN 2006 AND IN FEB 2006. THE PATIENT HAD BEEN ON A VAPOTHERM FROM WHICH IT SUCCESSFULLY WEANED TO STANDARD NASAL CANNULA IN DEC 2005. THERE WERE NO REPORTED INFECTIONS OR POSITIVE CULTURES ASSOCIATED WITH VAPOTHERM DURING THAT TIME. AS PART OF RECALL THE HOSPITALS VAPOTHERM DEVICES WERE RETURNED AND IN CONTROL OF VAPOTHERM, INC IN 2006. SUBSEQUENT THE LAST EXPOSURE TO VAPOTHERM IN DEC 2005 THIS PATIENT WAS NOT TREATED WITH A VAPOTHERM DEVICE.

    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 5 MO Other