On February 10, 2016, the FDA alerted that Dräger is recalling Oxylog Emergency Transport Ventilators because an electrical issue may cause the device to stop working if the control knobs (adjustment potentiometers) are not regularly used. If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
The Dräger Oxylog Emergency Transport Ventilators provide constant breathing support for adults and children. These ventilators are used in hospitals or during patient transport.
Dräger sent a letter to all customers with affected devices on December 21, 2015, informing them of this issue. The letter provides the following instructions to release the electrical contact resistance in the control knobs:
- Turn the device off.
- Rotate all control knobs at least ten times to the left and right stop (minimum and maximum value).
This recall is a Class I recall.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, February 2013 Report: Emergency Medical Services: Liability and Immunity for Medical Rescue
See also Medical Law Perspectives, December 2012 Report: When Urgency Leads to Errors: Liability for Emergency Care
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe