Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue

AUDIENCE: Risk Manager, Anesthesiology, Health Professional

ISSUE: GE Healthcare has initiated a voluntary field corrective action due to a potential safety issue that involves unresponsive buttons on the display of the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines.  Due to a manufacturing issue the buttons on the left, right, and bottom keypads may not always detect a user’s button presses. This may result in the inability to access certain menu functions which could possibly lead to delay in treatment. To date, no patient injuries have been reported with regards to this issue.

BACKGROUND: The affected units were manufactured between the dates of April 23, 2013 and July 22, 2013.

RECOMMENDATION: Clinicians may continue to use their Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines, but should be aware of this potential safety issue. GE Healthcare has begun notifying customers with affected units through an Urgent Medical Device Correction letter, which alerts users of the concern and provides instructions to mitigate the issue.  The instructions explain that to mitigate this issue, the user may notice that a button press may not actuate the desired function. Usually by pressing the key again, the device will respond as expected; if a button has no response, the menu function may be accessible through the use of the control wheel. The instructions direct that if none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative. GE Healthcare is following up with all customers and will correct all affected systems at no cost to customers. For additional information regarding this field action, please contact GE Healthcare’s Customer Service line (24 hours a day, 7 days a week) at 1-800-345-2700.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/16/2013 -Firm Press Release³]