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U.S. Department of Health and Human Services

Class 2 Device Recall Newport Medical Instruments e360 Ventilator

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 Class 2 Device Recall Newport Medical Instruments e360 Ventilatorsee related information
Date Initiated by FirmApril 18, 2014
Date PostedMay 09, 2014
Recall Status1 Terminated 3 on March 01, 2016
Recall NumberZ-1577-2014
Recall Event ID 68099
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductRecalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
Code Information Part Number: SBC2105A. Model Number(s): e360 Ventilator.  Serial numbers N11360719000 through N14360426029.
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett Inc. (dba Covidien LP)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact
303-530-6100
Manufacturer Reason
for Recall		Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.
FDA Determined
Cause 2		Component design/selection
ActionNewport Medical Instruments, Inc. (Newport), a wholly-owned subsidiary of Covidien is conducting a voluntary field corrective action via letters to be sent during the week of April 28, 2014. The letter titled "URGENT MEDICAL DEVICE FIELD SAFETY CORRECTIVE ACTION" informed customers of the recall by providing: reason for recall, product description, information on affected serial numbers regardless of software versions, issue identified, recommended actions to help mitigate risk to the patient, actions to eliminate the occurrence of this issue, important safety reminders, and contact information. Customers are to contact Technical Support Department to receive a software update kit, and then follow the instructions provided once the kit has been received. The attached verification and completion form should be completed and faxed.
Quantity in Commerce5,765
DistributionWorldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Texas, Virginia, and Washington; and, the countries of Algeria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Japan, Kazakhstan, Kenya, Lebanon, Liechtenstein, Lithuania, Mexico, Morocco, Namibia, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Republic of Armenia, Republic of KOS, Russia, Saudi Arabia, Singapore, Slovenia, S. Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Vietnam, and Yemen.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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