Drager Medical Inc Emergency Tansport Ventilator RecallFeb 16, 2016
The U.S. Food and Drug Administration (FDA) issued a Class 1 recall of the Drager Medical Inc. Emergency Transport Ventilator. A Class 1 Recall is the FDA's most serious recall issued when it is anticipated that a dangerous or defective product that likely could cause serious health problems or death. An emergency transport ventilator is used either in a hospital or when a patient is being transported and is used to provide sufficient and constant oxygen when and if a patient's breathing is compromised.
The recall is due to a problem with the control knob. If the ventilator fails to intervene, and the patient does not receive the necessary oxygen, serious injury or even death, may follow.
A letter was sent by Drager on December 15, 2015 informing all customers of the problem, reported the FDA. The letter instructs users with affected devices to release the electrical contact resistance in the control knobs; turn the device off and rotate all control knobs at least ten times to the left, then to the right stop (minimum and maximum value). Distribution dates are April 1, 2007 to December 12, 2015.
There were 117 devices recalled in the United States, distributed in Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Maine, 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 according to the FDA.