CareFusion EnVe and ReVel Ventilators Recalled (Class I) due to Power Connection Failure
Risk Managers, Biomedical Engineering, and Anesthesiology healthcare personnel are informed by the FDA that several lots of CareFusion 203, EnVe and ReVel ventilators are recalled due to power connection failure.
Background of CareFusion EnVe and ReVel Ventilators
The specific ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg).
FDA Alert on CareFusion EnVe and ReVel Ventilators
FDA’s reason for the recall is based on the potential for damage to the devices’ power cord adaptors which can cause loss of power and complete shut off. This could occur because the pins of the external power connector do not always align properly with the input port of the ventilator and could cause a short circuit the ventilator. This could lead to unexpected ventilator’s loss of power and cause serious patient injury or death.
The affected devices’ manufacture dates were from May, 2009 to August 2014 and their distribution dates from December 10, 2010 to August 6, 2014.
The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.
FDA Recommendation on CareFusion EnVe and ReVel Ventilators
“CareFusion sent customers a Product Recall Notice letter on August 8, 2014. The letter identified the product, problem and actions to be taken. The letter also said that two new power adaptor accessory kits for the ReVel and EnVe ventilators would be sent to correct the problem. A complete listing of affected lot numbers may be found in the recall notice.”
Contacting the FDA to report cases with CareFusion EnVe and ReVel Ventilators
In case of detection of adverse events or side effects related to the use of CareFusion EnVe and ReVel Ventilators, 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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