Monitor, Apnea, Home Use
Anesthesiology · 21 CFR 868.2377
Same as the identification for product code FLS, just add home use
Recent MDR events
54 adverse event reports on file
- SMART MONITOR 2Dec 28, 2022MalfunctionPhilips / Respironics, Inc.MW5114075
- SMART MONITOR 2PSLNov 16, 2018MalfunctionCircadiance, Llc3006182632-2018-00027
- SMART MONITOR 2PSLNov 16, 2018MalfunctionCircadiance, Llc3006182632-2018-00026
- SMART MONITOR 2PSLAug 28, 2018MalfunctionCircadiance, Llc3006182632-2018-00025
- SMART MONTIOR 2PSMay 4, 2018MalfunctionCircadiance, Llc3006182632-2018-00016
- SMART MONITOR 2PSMay 4, 2018MalfunctionCircadiance, Llc3006182632-2018-00020
- SMART MONITOR 2PSMay 4, 2018MalfunctionCircadiance, Llc3006182632-2018-00014
- SMART MONITOR 2PSMay 4, 2018MalfunctionCircadiance, Llc3006182632-2018-00019
- SMART MONITOR 2PSMay 4, 2018MalfunctionCircadiance, Llc3006182632-2018-00012
- SMART MONITOR 2PSMay 4, 2018MalfunctionCircadiance, Llc3006182632-2018-00015
Event type breakdown
Recalls
3 recall events for this product code
- Childrens Medical VenturesTerminatedJun 13, 2014
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
Z-1789-2014 · View FDA record ↗ - Respironics, Inc.TerminatedApr 24, 2008
APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Z-1086-2008 · View FDA record ↗ - Respironics, Inc.TerminatedApr 24, 2008
Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysvi
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Z-1091-2008 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
2 clearances for this product code