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U.S. Department of Health and Human Services

Safety

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Vapotherm 2000i Respiratory Gas Administration Device

Audience: Neonatologists, Respiratory healthcare professionals and hospital clinical managers

[UPDATE posted 12/20/2005] See update of safety information about Ralstonia spp. associated with Vapotherm Respiratory Gas Administration Device. The FDA continues to collaborate with the CDC to determine the scope of the contamination with Ralstonia spp., and other opportunistic pathogens. Further information is provided in the updated MMWR from CDC.

[Posted 10/27/2005] FDA issued a Preliminary Public Health Notification to inform healthcare professionals of new information about a possible association between the Vapotherm 2000i Respiratory Gas Administration device, used to add moisture and warm breathing gases through a nasal canula in patients receiving supplemental oxygen, and the occurrence of positive Ralstonia spp. cultures. The association was first reported in a MMWR article issued by CDC on October 21, 2005. The new information is described in the web notice at the link below. FDA recommends that providers consider this new information in deciding whether and when to use the Vapotherm device with patients.

[December 20, 2005 - Update: Preliminary Public Health Notification - FDA]
[December 20, 2005 - Morbidity and Mortality Weekly Report - CDC]
[October 27, 2005 - Preliminary Public Health Notification - FDA]
[October 19, 2005 - Morbidity and Mortality Weekly Report - CDC]