GE Healthcare recalled Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC), manufactured between February 10, 2012 through October 2, 2012 and distributed through April 2014 because the carbon dioxide detectors may fail.
These devices are used in hospitals and other health care facilities for monitoring carbon dioxide and respiration rates in patients weighing over 11 pounds (5 kg). The affected carbon dioxide detectors may fail or provide incorrect carbon dioxide 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 carbon dioxide (hypercapnia). Death may also occur as a result of low carbon dioxide values.
The affected Single-Width Airway Modules (E-miniC) include Serial Numbers 6818561 through 6898777. The affected Extension Modules N-FC and N-FCREC include Serial Numbers 6799191 through 6905206. The serial number can be found on the device plate attached to the module. Modules serviced with FRU (Field Replaceable Unit) catalog number M1013204 (miniC Unit, N-FCREC) between February 2012 and May 2014 may also be affected by this recall.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe