FDA
GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550
Datex-Ohmeda Aisys
Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.
GE Healthcare "Urgent Medical Device Correction" letters dated 8/12/08 were sent on 8/20/08 individually to Health Administrator/Risk Manger, Head of Anesthesia and Director of Clinical Engineering. The letters described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The Safety Instructions state that the machines can be safely used as long as the following guidelines are followed:
1. Carry out the daily system checkout for any system in use.
2. The Aisys Anesthesia will alert the user both visually and audibly if it detects a fault condition.
3. Have an alternative method of anesthesia available at all times.
Once each machine has been corrected an "Update" will be provided by the service technician responsible for the correction. Each customer/machine will receive a "GE Healthcare Urgent Medical Device Correction Update" letter which informs the customer that this correction is a follow-up activity to the letter that was sent earlier.