Newport Medical e360 Ventilator Component Recalled for Audible Alarm Failure
Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a critical medical device where a failure of the audible alarm could lead to delayed response to patient distress, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nellcor Puritan Bennett Inc. (dba Covidien LP) is recalling 5,765 single board computer components (part number SBC2105A) used in the Newport Medical Instruments e360 Ventilator. The recall is due to reports that the audible alarm may not sound when the ventilator is in an alarm state. The visual and remote alarms continue to operate normally.
The affected components are identified by serial numbers N11360719000 through N14360426029. These components are intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should contact the manufacturer for instructions on how to address the issue.
The recalled product
- Product
- 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
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Hazard
- Affected units
- 5,765
Distribution
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