A Class I recall has been issued for GE’s Healthcare Aestiva/5 7900 Ventilator, the U.S. Food & Drug Administration (FDA) just announced. A Class I is the agency’s most serious designation indicating that this recall involves a situation in which there exists a reasonable probability that use of the recalled medical device will cause serious adverse health consequences or death. The agency indicated that it notified healthcare professionals of a Class I Recall of the GE Healthcare Aestiva/5 7900 Ventilator.
There is a potential for two vaporizers to deliver each agent simultaneously, which could result in over-delivery of a single agent if both vaporizers contain the same agent, or in delivery of more than one agent. Unrecognized overdose with simultaneous inhaled anesthetics can result in hypotension (low blood pressure), arrhythmias (irregular breathing), and bradycardia (low heart rate). Should this occur, persist, and remain unrecognized, circulatory shock might occur. The FDA notes that this ventilator may cause serious adverse health consequences, including death.
The recalled ventilator is intended for continuous breathing support in patients requiring mechanical ventilation during surgical procedures and is used in hospitals and other health care facilities. The Aestiva/5 7900 Ventilator was manufactured on July 2, 2010 and the recall involves products with the following serial numbers: AMRP01031, AMRP00966, AMRP01030, AMRP00968, AMRP00967, AMRP01033, AMRP00970, AMRP00969
On April 10, 2012, the firm sent an “Urgent Medical Device Correction” letter to its customers describing the safety issue, safety instructions, affected product details, product corrections, and contact information.
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 which can be accessed at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
GE Healthcare, LLC is located at 9900 Innovation Drive, Wauwatosa, Wisconsin, 53226 and may be reached at 1.262.513.4122.