GE Anesthesia System Problems May Result in Overdelivery: Warning

GE Healthcare has announced a voluntary field correction action for two anesthesia delivery systems, due to potential software problems that may cause the machines to over deliver medication, posing serious and potentially life-threatening health risk for patients.  

An Avance, Aisys and Avance CS2 anesthesia delivery systems field action was announced by the FDA on October 15, after the manufacturer recognized the software programs may allow over-delivery of medication when using the Pressure Control Ventilation-Volume Guarantee Mode (PCV-VG). To date no injuries or incidents have been reported.

The systems are used to deliver anesthesia to patients and are controlled by a software program that allows the user to input a particular amount of fluid to be disbursed. The affected systems may fail to deliver the correct amount of anesthesia fluid if the user transitions from mechanical PCV-VG mode to manual ventilation because changing the mode will also change the set tidal volume of anesthesia to be delivered.

Over delivery of anesthesia may cause moderate to severe health consequences such as nausea, vomiting, hallucinations, and under certain circumstances cause reduction in blood pressure. In more severe circumstances patients may suffer from dementia, mental impairment, and even death.

The field action consists of Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 or 10.00 software programs manufactured by GE Healthcare. The systems were manufactured between February 2011 and July 2013 where they were distributed for sale to various healthcare providers.

GE announced that users should not adjust the ventilator tidal volume while in the manual ventilation mode to avoid over delivery of anesthesia medication.

GE Healthcare initiated its voluntary field action by sending an Urgent Medical Device Correction letter alerting the customers of the concerns and instructions on how to avoid the issue. The letter also contains instructions on how to contact GE Healthcare to correct the systems for free. Customers with affected devices should contact GE Healthcare Customer Service center at 1-800-345-2700 or visit them online at gehealthcare.com. Customers may also contact the FDA at 1-800-FDA-1088 or 1-888-INFO-FDA for further questions.