Voluntary Field Corrective Action Issued for GE Healthcare's Avance, Aisys and Avance CS2 Anesthesia Delivery Systems
Tue, 15 Oct 2013 17:47:00 -0400
Contact:Consumer:(800) 345-2700Media:Annette Busateri(262) firstname.lastname@example.org FOR IMMEDIATE RELEASE - October 15, 2013 - GE Healthcare has initiated a voluntary field corrective action for the Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or 10.00 (Avance CS2) software due to a potential safety issue. The affected units were manufactured from February 2011 through July 2013.Clinicians may continue to use their Avance, Aisys and Avance CS2 anesthesia delivery system, but should be aware that a unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume when using the Pressure Control Ventilation – Volume Guarantee (PCV-VG) mode. All safety over-pressure controls and alarms will continue to function properly. However, over delivery of tidal volume this may result in alterations to blood flow within the thorax that, under extreme circumstances, may result in gradual reductions in blood pressure. The unique sequence of inputs includes transitioning from mechanical PCV-VG mode to manual ventilation, changing the set tidal volume (while in manual mode), and then returning to mechanical PCV-VG mode. To avoid this situation, when using PCV-VG mode, do not adjust the ventilator tidal volume while in a manual ventilation mode. At any time during the use of the device should an over delivery of tidal volume occur while in PCV-VG mode, transitioning to a different ventilation mode will resolve the 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. GE Healthcare is following up with all customers and will correct all affected systems at no cost to customers. To date, no patient injuries have been reported with regards to this issue.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.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or email), orCall FDA 1-800-FDA-1088.
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