Medical Device Safety and Recalls: CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

 



Title: Medical Device Safety and Recalls: CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure

A recall has been issued for CareFusion 203, Inc., EnVe and ReVel ventilators 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.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm418110.htm


This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

[Index of Archives]     [CDC News]     [NIH News]     [USDA News]     [Steve's Art]     [Camping in Yosemite]     [PhotoForum]     [SB Lupus]     [STB]

  Powered by Linux