GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC): Class I Recall - CO2 Detector May Fail Leading to Injury
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