Newport e360 Ventilator…

Date posted by the FDA

Sept. 4, 2009

Status

Terminated

Filed by

Newport Medical Instruments Inc

Product

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).

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

Distribution pattern

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 Republic, Ecuador, Egypt, England, Finland, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Japan, Jordan, Kazahkstan, Kenya, Korea, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nambia, Nepal, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, AUE, Ukraine, United Kingdom, Yemen Republic and Zimbabwe.

Quantity

4,117 units (214 Domestically; 3,903 Internationally)

Codes and lots

Serial Numbers for the Domestic Units: N07361211863 N06360910375 N06360610268 N09360413995 N07360110859 N07361111725 N07361111620 N06360710310 N06360710311 N06360710312 N07360110797 N08360812873 N06361210693 N07360911465 N36360410225 N07360110864 N07360110870 N09360313832 N07361111713 N08360512383 N08360512384 N08360512385 N08360512386 N07361211793 N06360910351 N08360712658 N08360712659 N08360712660 N08360712661 N08360712662 N08361013165 N08361013166 N08361013167 N08361013168 N08361013169 N06361210693 N07360110855 N08361213295 N09360113451 N06360610258 N07360110853 N06360610271 N06361010529 N06361010532 N07360110825 N07360811393 N08360212053 N07361211869 N07361211870 N07361211871 N07361211872 N09360213550 N06360810339 N06360910350 N06360910352 N06360910354 N06360910388 N06360910389 N07360411127 N07360811396 N07361111626 N07361111627 N07361111711 N07361111712 N08360512396 N08360612528 N08360612561 N08360712687 N08360712688 N08360712689 N08360712690 N08360712691 N08360712692 N08360712693 N08360712694 N08360712695 N08360712696 N08360712697 N08360712698 N08360712699 N08360712700 N08360712701 N08360712702 N08360712703 N08360712704 N08360712705 N08360712706 N08360712707 N08360712708 N08360712709 N08360712710 NO8360712709 N06360710307 N06360710308 N06360710309 N06360710313 N06360710314 N06360610280 N06361010516 N06361010518 N06361010519 N06361010522 N06361010536 N07360110856 N07360110862 N07360110867 N07360210926 N07360911464 N07360911489 N07360911490 N07360210952 N07360210953 N07360210954 N08361013107 N08361013108 N08361013109 N08361213283 N08361213284 N08360512381 N08360512382 N08360512398 N08360512399 N08360512400 N08360512402 N06361010542 N06361010543 N06361010544 N06361010545 N06361010546 N06361010547 N06361010548 N06361010550 N06361110551 N06361110552 N06361110553 N06361110554 N06361110555 N06361110556 N06361110557 N06361110558 N06361110559 N06361110560 N06361110561 N06361110562 N06361110563 N06361110564 N06361110572 N06360910373 N07306011235 N07360611236 N07360711360 N07360711361 N07360711363 N07360711364 N07360711368 N07360711372 N07360911491 N07360911492 N07361211769 N07361211783 N07361211784 N07361211785 N07361211786 N07361211787 N07361211788 N07361211789 N07361211790 N07361211791 N07361211792 N08360111874 N08360111875 N08360512395 N08361013110 N08361013111 N08361013112 N08361013113 N08361013114 N07360110873 N06361010536-R N07361211812 N07361211813 N08361013175 N08360111987 N08360111988 N08360111989 N08360111990 N06361010533 N07360110796 N07360110852 N07360110860 N07360110868 N07360110876 N06361010531 N07360210951 N07360210964 N07360110866 N07360811397 N07360110898 N07360210944 N07360811380 N07360811384 N07360811386 N07360811398 N07360811401 N07360811402 N07360811403 N07360811427 N08360811403 N07360711362 N07360711365 N07360811387 N09360213549 N06361010534 N07360110863; and Serial Numbers for the International Units: N06360910392 N06360910400 N06360910426 N06361110580 N07361111637 N07361111638 N09360313710 N06360910352 N07360110878…

Recall started

Dec. 15, 2008

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-2029-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2029-2009. The agency record governs; check it and the company before acting.