The Getinge Flow-c and Flow-e anesthesia systems are intended to provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe. These systems can also support the breathing of people with limited ability to do so themselves. It is used for patients ranging in age from newborns to adults and operated by trained anesthesiologists in hospital setting
If the on/off switch breaks, the suction unit will not work to remove fluids such as phlegm, blood, or stomach content from the patient’s mouth and/or airways. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
This issue could cause a delay during a procedure or in between procedures if the anesthesiologist needs to find another way to suction fluids. Additionally, if the suction device is not working for a longer period of time, these fluids could block a patient’s breathing. The risks of such a blockage may include:
- Inability of oxygen to get into the blood;
- An infection in the lungs that prevents oxygen from getting to the blood;
- Brain injury caused by lack of oxygen to the brain;
There have been 21 complaints, no injuries and no deaths associated with the use of this device. Roughly 64 devices that were distributed between June 2, 2020 to Feb. 15, 2022 have been recalled.