Recalls

GE Healthcare issues corrective action for defective anesthesia delivery system

GE Healthcare logo1 GE Healthcare issues corrective action for defective anesthesia delivery system GE Healthcare has issued a field corrective action for the Avance, Aisys and Avance CS2 anesthesia delivery systems due to a potential safety issue. Apparently, 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 mode. All safety over-pressure controls and alarms will continue to function properly; however, over delivery of tidal volume may result in altercations to blood flow within the thorax that, under extreme circumstances, could result in gradual reductions in blood pressure. To date, GE Healthcare has received no reports of adverse events associated with this issue.

Clinicians have been notified about the problem and instructed on what to do to avoid this malfunction. GE Healthcare is also correcting the defects with the devices at no charge to its customers.

An anesthetic is a drug that causes anesthesia, a reversible loss of sensation. It is generally administered to patients prior to and/or during surgery or medical procedures. Anesthetics are usually grouped into one of two categories – general anesthetics, which cause a reversible loss of consciousness, and local anesthetics, which result in a reversible loss of sensation for a limited region of the body while maintaining consciousness.

Health care providers and patients should report any adverse reactions associated with this recall to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.htm.

Source: FDA