Nellcor™ Bedside SpO2 Patient Monitoring System

Issue

Medtronic is issuing a safety notification for its Nellcor™ Bedside SpO2 Patient Monitoring System. This notice follows receipt of multiple reports from customers stating that the device alarm was not heard or recognized, resulting in a delay to treatment or lack of response to low oxygen saturation, respiratory failure, or arrythmia. There have also been reports of death during some of these circumstances. Through investigation, Medtronic employees found that PM100N monitors were not set into homecare mode when in use outside of a hospital or other professional care setting. Homecare mode simplifies device operation and prevents lay users from making changes to patient mode and alarm setting. Remaining in standard mode allows for users to adjust the alarm limits and patient mode. Based on available information, the Nellcor™ bedside SpO2 patient monitors continues to be safe for use in patient care. While our investigation continues, this recall is being implemented to reiterate existing information available in the operator's and service manuals and the home use guide for both the PM100N and Libra 10005941 with possible additional activities initiated when the initial investigation has been completed. Recall start date: June 23, 2025