Class 1 Recall: Dräger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working
Class 1 Recall: Dräger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working
Tue Jan 05 2016
Class 1 Recall: Dräger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working
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.
Recalled Device
- All Dräger Perseus A500 anesthesia workstations manufactured from June 1, 2013 to September 30, 2015.
- Distribution Dates: February 1, 2015 to September 30, 2015
- Devices Recalled in the U.S.: 34 units total were distributed to hospitals in Illinois, Maine, New York, Ohio, Pennsylvania, and Wisconsin
- A list of affected serial numbers is available on FDA’s website
Device Use
The Dräger Perseus A500 Anesthesia Workstation provides anesthesia and breathing support for children and adults. This medical device is used in hospitals.
Reason for Recall
Dräger is recalling the Perseus A500 anesthesia workstation because a faulty power switch 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. This could cause patients to suffer serious adverse health consequences, including injury or death.
The company has received one report of this issue occurring, with no injuries and no deaths.
Who may be affected
- Health care providers using the Perseus A500.
- All patient groups who may be given anesthesia or breathing support with this device.
What to Do
Dräger 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 Dräger service representative will contact customers to schedule a replacement, free of charge.
Until the replacement takes place, Dräger recommends that users operate affected Perseus A500 workstations under continuous supervision.
Contact Information
Customers with questions are instructed to call Dräger technical support: 1-800-543-5047
Date Recall Initiated
November 12, 2015
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.