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Terminated

Recalled 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.

FDA Recall Z-1577-2014 · Posted 2014-05-09

Recalling FirmNellcor Puritan Bennett Inc. (dba Covidien LP)
Recall StatusTerminated
Product CodeCBK
Date Initiated2014-04-18
Date Terminated2016-03-01
Product Quantity5,765

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.

Firm Action

Newport 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.

Root Cause

Component design/selection

Distribution Pattern

Worldwide 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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