USFDA Medical Device Recall Alert : CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure...

Recall Class: Class I

Date Recall Initiated: August 5, 2014

Products: CareFusion 203, EnVe and ReVel ventilators

• Manufacturing Dates: May, 2009 - August 2014
• Distribution Dates: December 10, 2010 - August 6, 2014.

Lot Numbers: See Affected Lot Numbers below. (Added October 17, 2014)

Use: 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.

Recalling Firm:
CareFusion 203, Incorporated
17400 Medina Road, Suite 100
Minneapolis, Minnesota 55447-1341

Reason for Recall:
CareFusion 203 recalled these devices because of the potential for damage to their power cord adaptors which can cause loss of power and complete shut off.

The EnVe and ReVel ventilators can be operated using either batteries or external power sources (AC or auto lighters). The firm recalled these devices because they found that 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. 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.

Public Contact: For questions regarding the operation and/or servicing of affected CareFusion ventilators in the United States, 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 SupportCenter@carefusion.com.