Recall Z-2029-2009 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).
| Date | Sep 4, 2009 (initiated Dec 15, 2008) |
| Status | Terminated |
| Reason | In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced unexpected device alert alarms. Newport's investigation into these complaints confirmed that the 3.3 software responds too quickly to certain situations, giving a false device alert. Newport condu |
| Root cause | Software design |
| Action | Newport Medical initally sent out a Field Correction Notice to a limited number consignees dated December 17, 2008 and then the notice was expanded to include all e360 consignees dated June 15, 2009. The firm notified consignees that they have revised the e360 software to version 3.8. A customer verification form was attached to verify upgrade completion. For further questions, contact Newport Customer Technical Support Department at 1-800-451-3111 or +1-714-427-5811 Extension 500. |
| Quantity | 4,117 units (214 Domestically; 3,903 Internationally) |
| Distribution | Worldwide Distribution -- US (including AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, ME, MI, NJ, NM, NY, OH, OK, OR, PA, UT and VA), Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Czech Republic, Dominican Rep |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053502 | NEWPORT E360 VENTILATOR Newport Medical Instruments, Inc., Jan 10, 2006 |