Company:Newport Medical Instruments Inc.
Date of Enforcement Report 8/3/2011
Class ll:
PRODUCT
Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal or tracheotomy [ET] tube) or non-continuous (mask) ventilator support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility. Recall # Z-2468-2011
REASON
Regarding e360 ventilators that were shipped with a different software version from what the customers ordered.
RECALLING FIRM/MANUFACTURER
Newport Medical Instruments Inc., Costa Mesa, CA, by letter on October 27, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide, New Mexico and country of Quito, Ecuador
