On December 22, 2015, Dräger Medical Inc. recalled the 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.
Dräger Oxylog Emergency Transport Ventilators provide constant breathing support for adults and children. These ventilators are used in hospitals or during patient transport.
The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these ventilators may cause serious injuries or death.
The recalled devices are the Dräger Oxylog 2000 plus, Oxylog 3000, and Oxylog 3000 Plus Ventilator; catalog numbers: 5705080, 2M86300, 2M86965, 5704813, 5704831. The ventilators were distributed in the U.S. from April 1, 2007 to December 12, 2015. The ventilators were distributed in Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming.
Dräger sent a letter to all customers with affected devices on December 21, 2015, informing them of this issue. The letter provides instructions to release the electrical contact resistance in the control knobs. The operator should turn the device off, then rotate all control knobs at least 10 times to the left and right stop (minimum and maximum value).
Customers with questions about the recall may call Dräger at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). Customers with questions about the operation or servicing of Dräger Oxylog ventilators may contact Dräger Service Technical Support at 1-800-543-5047 (press 4 at the prompt).