  |
AUDIENCE: Critical Care Medicine, Risk Manager, Biomedical Engineer
ISSUE: The affected CO2 detectors may fail or provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients. Patients may experience an inadequate exchange of gases (hypoventilation), causing an increased concentration of CO2 (hypercapnia). Death may also occur as a result of low CO2 values.
BACKGROUND: These devices are used in hospitals and other health care facilities for monitoring CO2 and respiration rates in patients weighing over 11 pounds (5 kg).
RECOMMENDATION: On June 11, 2014, the firm sent an Urgent Medical Device Correction letter to their customers. The letter identified the affected products and problem and provided safety instructions. Customers should read the letter and follow the instructions provided.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the FDA Recall notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm406730.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
