October 10, 2014 — The CareFusion EnVe and ReVel ventilators have been recalled because a defective power adaptor can cause a loss of power and shut off the machine, resulting in a serious patient injury or death.
CareFusion has received 256 reports of power failures, but there are no reports of patient injury or death. Even so, the FDA has designated the recall as “Class I,” which is the most serious type of recall.
“The pins of the external power connector did not always align properly with the input port of the ventilator. This misalignment can damage the pins on the connector and possibly short circuit the ventilator. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly.”
The machines included in the recall were manufactured beginning in May 2009 and they were sold until August 2014. The EnVe and ReVel ventilators are designed to provide respiratory support or mechanical ventilation in hospitals, during transport, or at home.
Customers who purchased the ventilators were notified in August with a letter that explained the problem and corrective actions. CareFusion will provide a free replacement power adaptor accessory kit.
After the kit is received, CareFusion recommends:
- Plug in the new AC Power Adapters and return a confirmation for each one used.
- Identify the ventilator serial numbers and/or serial numbers of AC Power Adapters, and Auto Lighter Power Cords which have been attached.
Do I have a Ventilator Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting ReVel and EnVe ventilator induced injury cases in all 50 states. If you or somebody you know has been injured by a defective ventilator, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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