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U.S. Department of Health and Human Services

Class 2 Device Recall Newport e360 Ventilator

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 Class 2 Recall
Newport e360 Ventilator
see related information
Date Posted May 19, 2010
Recall Status1 Terminated on August 18, 2011
Recall Number Z-1617-2010
Recall Event ID 55504
Premarket Notification
510(K) Number
K053502 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Newport e360 Ventilator 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). 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.
Code Information All serial numbers beginning with N093609XXXXX, N093610XXXXX, N093611XXXXX, and N093612XXXXX
Recalling Firm/
Manufacturer
Newport Medical Instruments Inc
1620 Sunflower Ave
Costa Mesa, California 92626
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on Printed Circuit Board (PCB) 2104A in the Newport e360 ventilator. Ventilators manufactured between September and December 2009 are affected by this field correction. All affected ventilators require the replacement of the PCB2104A board to avoid early failure of t
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Newport Medical, sent a "Field Correction Notice" dated April 14, 2010, to all customers. The notice describes the product, problem and actions to be taken by the customers. The customers were instructed to: 1) provide your affected customers with a copy of this letter and advise them to pay close attention to pressure errors which can be an early warning sign of the pressure transducer failure; 2) Schedule their ventilators for replacement of the PCB2104A board as quickly as possible to avoid any unanticipated disruption in their use of their product; 3) Contact our Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers) to request the replacement kits you will need; and 4) Complete the attached form and return it to Newport Medical as you complete your PCB2104A replacements. This will allow us to ensure that all affected ventilators have been addressed and close this field action. For questions, customers were instructed to contact Newport Medical Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers).
Quantity in Commerce 990
Distribution Worldwide distribution: USA including states of CA, KY, NM, NY, UT and internationally to: Armenia, Bolivia, Brazil, Bulgaria, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Malaysia, Mauritius, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, South Africa, Sri Lanka, Syria, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, Vietnam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
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