GE Healthcare Aestiva/5 7900 Ventilator Recalled due to Unrecognized Overdose Potential

Risk Managers and healthcare professionals are informed by the FDA that GE Healthcare Aestiva/5 7900 Ventilator is recalled because there is a potential for unrecognized overdose. This can lead to serious adverse events including circulatory shock and death.

Background of Aestiva/5 7900 Ventilator

Aestiva/5 7900 Ventilator, by GE Healthcare, LLC, is used in hospitals and other facilities to provide breathing support for patients who require ventilation support during surgery.

The ventilator was manufactured on July 2, 2010.

FDA Alert on Aestiva/5 7900 Ventilator

FDA’s reason for the recall is that two vaporizers of the Aestiva/5 7900 Ventilator might deliver each agent at the same time. Unrecognized overdose can lead to hypotension, bradycardia and, if it persists, to circulatory shock and other serious adverse events, including death.

The affected serial numbers are: AMRP01031, AMRP00966, AMRP01030, AMRP00968, AMRP00967, AMRP01033, AMRP00970 and AMRP00969.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Aestiva/5 7900 Ventilator

“On April 10, 2012, the firm sent an “Urgent Medical Device Correction” letter to their customers. The letter described the safety issue, safety instructions, affected product details, product corrections and contact information.”

Contacting the FDA to report cases with Aestiva/5 7900 Ventilator

In case of detection of adverse events or side effects related to the use of Aestiva/5 7900 Ventilator, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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