FDA MedWatch - CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure

AUDIENCE: Risk Manager, Biomedical Engineering, Anesthesiology

ISSUE: FDA notified health professionals and their medical care organizations of a Class I Recall of these products. There is a potential for damage to their power cord adaptors which can cause loss of power and complete shut off. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly. Ventilator shut-off from power failures may lead to serious patient injury or death. The company has received 256 reports of the incident with no reported injuries or deaths.

BACKGROUND: The CareFusion EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg).  They are used in hospitals, during transport of a patient and at home to provide constant or intermittent respiratory support. The recalled products were manufactured from May, 2009 to August 2014 and distributed from December 10, 2010 to August 6, 2014.

RECOMMENDATIONS: 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.

For questions, call the CareFusion Recall Center at 888.562.6018, Monday through Friday, 7:00 a.m. – 4:00 p.m., Pacific Time or via email at [email protected].

Read the MedWatch safety alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418344.htm