Skip directly to search Skip directly to A to Z list Skip directly to site content
CDC Home

Update: Ralstonia Species Contamination Associated with Vapotherm® 2000i Respiratory Gas Humidifier Systems --- United States, 2005--2006

This report updates previously published information regarding contamination of Vapotherm® 2000i respiratory gas humidifiers (Vapotherm, Inc., Stevensville, Maryland) with Ralstonia species (1--3). The manufacturer took corrective actions (Table) and reintroduced the device in January 2007, after meeting Food and Drug Administration (FDA) 510(k) submission requirements.*

CDC and FDA recommend that clinicians using the Vapotherm device ensure that they are following the most recent recommendations and have the most recent instructions for the device and its components; the 2000i operating instruction manual can be obtained by contacting Vapotherm, Inc., by telephone: 410-604-3977 or 866-827-6843, fax: 410-604-3978, or e-mail: info@vtherm.com. Additional information regarding use of the reintroduced device is available from FDA at http://www.fda.gov/cdrh/safety/020107-vapotherm.html.

FDA encourages reporting of adverse events related to the use of medical devices; such reports can be submitted to MedWatch, FDA's voluntary reporting program, by telephone: 1-800-FDA-1088, by fax: 1-800-FDA-0178, by mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787, or online: http://www.fda.gov/medwatch/report.htm. Clinicians who would like to conduct surveillance for health-care--associated infections in patients using the Vapotherm device can use strategies similar to those used for surveillance of ventilator-associated infections.

Reported by: A Srinivasan, MD, National Center for Preparedness, Detection, and Control of Infectious Diseases (proposed); M Jhung, MD, EIS Officer, CDC.

References

  1. CDC. Ralstonia associated with Vapotherm® oxygen delivery device---United States, 2005. MMWR 2005;54:1052--3.
  2. CDC. Update: Ralstonia associated with Vapotherm® oxygen delivery device---United States, 2005;54:1104--5.
  3. CDC. Update: public health notification regarding Ralstonia associated with Vapotherm® respiratory gas administration devices---United States, 2005. MMWR 2005;54:1286--7.

* Additional information is available at http://www.fda.gov/cdrh/devadvice/314.html.

Table

Table 1
Return to top.



Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.


All MMWR HTML versions of articles are electronic conversions from typeset documents. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version (http://www.cdc.gov/mmwr) and/or the original MMWR paper copy for printable versions of official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.

 
USA.gov: The U.S. Government's Official Web PortalDepartment of Health and Human Services
Centers for Disease Control and Prevention   1600 Clifton Rd. Atlanta, GA 30333, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348 - Contact CDC–INFO
A-Z Index
  1. A
  2. B
  3. C
  4. D
  5. E
  6. F
  7. G
  8. H
  9. I
  10. J
  11. K
  12. L
  13. M
  14. N
  15. O
  16. P
  17. Q
  18. R
  19. S
  20. T
  21. U
  22. V
  23. W
  24. X
  25. Y
  26. Z
  27. #