Monitor, Apnea, Facility Use
FDA adverse event reports and recall history for monitor, apnea, facility use (product code FLS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 620
- Deaths
- 82
- Injuries
- 21
- Malfunctions
- 494
Reports per year
Source: FDA adverse event reports by year received, 2004–2019. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2009-05-19TerminatedProcess design
SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
Audible alarm failure.
- 2008-04-24TerminatedEnvironmental control
Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Monitor monitor, apnea, facility use automatically
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