Draeger Recalls Anesthesia Machine Due to Unexpected Shutoff

Draeger Recalls Anesthesia Machine Due to Unexpected Shutoff
Image: NCCC
December 28, 2015

An anesthesia apparatus from Draeger that can turn off unexpectedly is being recalled.

The Food and Drug Administration (FDA) has announced a Class I recall for all Draeger Perseus A500 anesthesia workstations manufactured from June 1, 2013 to September 30, 2015. A Class I recall is the most serious, indicating that the issue can cause serious injury or death.

The recall comes because of a faulty power switch that may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen.

The company has received one report of this issue occurring, with no injuries and no deaths.

Thirty-four units were distributed to hospitals in Illinois, Maine, New York, Ohio, Pennsylvania, and Wisconsin. For a list of the serial numbers of affected models, see the FDA release.

Draeger sent an urgent field safety notice to all customers with affected devices on November 10, 2015, informing them of this issue. The letter indicates that the power switch of affected workstations must be replaced. A Draeger service representative will contact customers to schedule a replacement, free of charge.

Until the replacement takes place, Draeger recommends that users operate affected Perseus A500 workstations under continuous supervision.

Customers with questions about the recall can contact Draeger at (800) 543-5047.