Monitor, Apnea, Facility Use
Anesthesiology · 21 CFR 868.2377
Recent MDR events
620 adverse event reports on file
- SMARTMONITOR 2Apr 24, 2019MalfunctionCircadiance Llc3006182632-2019-00001
- SMART MONITOR 2Nov 26, 2018MalfunctionCircadiance, Llc3006182632-2018-00028
- SMART MONITOR 2Aug 30, 2018InjuryCircadiance3006182632-2018-00023
- SMART MONITOR 2Aug 29, 2018MalfunctionCircadiance, Llc3006182632-2018-00024
- SMART MONITOR 2May 4, 2018MalfunctionCircadiance, Llc3006182632-2018-00010
- SMART MONITOR 2Aug 12, 2016MalfunctionCircadiance Llc3006182632-2016-00003
- SMART MONITOR 2Jul 6, 2016MalfunctionCircadiance Llc.3006182632-2016-00002
- SMARTMONITOR 2Mar 29, 2016MalfunctionCircadiance, Llc.3006182632-2016-00001
- SMARTMONITOR 2 W/O MODEMDec 10, 2015MalfunctionCircadiance, Llc3006182632-2015-00004
- SMARTMONITOR 2 W/ MODEMDec 3, 2015InjuryCircadiance, Llc3006182632-2015-00003
Event type breakdown
Recalls
2 recall events for this product code
- Respironics, Inc.TerminatedMay 19, 2009
SmartMonitor 2 Infant Apnea Monitor.
Audible alarm failure.
Z-1411-2009 · View FDA record ↗ - Respironics, Inc.TerminatedApr 24, 2008
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,
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Z-1093-2008 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
16 clearances for this product code
- Respironics Georgia, Inc.Jan 11, 2002
K011597 · SMARTMONITOR 2, MODEL 4000
- Ilife Systems, Inc.Jan 12, 2000
K991087 · HANNAH WIRELESS VITAL SIGNS MONITOR
- Airsep Corp.Oct 25, 1996
K962865 · REMBRANDT SYSTEM
- Protocol Systems, Inc.Feb 2, 1996
K951246 · PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
- Hogan & HartsonOct 30, 1989
K894973 · RESPITRACE PLUS
- Litton Medical ElectronicsFeb 13, 1984
K832999 · RESPIRATION MONITOR
- Alternative Design Systems, Inc.Oct 14, 1983
K830778 · MONITORING KIT AMK-1
- New Dimensions IN Medicine, Inc.Oct 6, 1982
K822077 · RESPIRATION MONITOR TYPE MR-10