BEUDAMED
    FDA Recall 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.

    Recall: Z-1577-2014 · Initiated April 18, 2014

    Recall

    Recall Number
    Z-1577-2014
    Event Number
    68099
    Firm
    Nellcor Puritan Bennett Inc. (dba Covidien LP)
    FEI Number
    2936999
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 18, 2014
    Posted
    May 9, 2014
    Terminated
    March 1, 2016
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    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.

    Reason

    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.

    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.

    Distribution

    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.

    Quantity

    5,765