Spirometer, Monitoring (w/wo Alarm)
Anesthesiology · 21 CFR 868.1850
Recent MDR events
136 adverse event reports on file
- GAS MODULE 3Mar 30, 2020DeathShenzhen Mindray Bio-medical Electronics Co., Ltd2221819-2020-00006
- GAS MODULE 3Mar 26, 2020DeathShenzhen Mindray Bio-medical Electronics Co., Ltd3009156722-2020-00006
- SYSTEM ONE RESPIRATORFeb 27, 2018InjuryPhills / Respironics, Inc.MW5075570
- MULTIPARAMETER PHYSIOLOGIC MONITOR MODULENov 9, 2017MalfunctionGe Healthcare Products7013685
- AMBU ACTION PUMPDec 14, 2016InjuryAmbuMW5066762
- GAS MODULEMay 29, 2015MalfunctionMindray Bio-med Electronics Co. Ltd.2221819-2015-00233
- GAS MODULE IIIFeb 6, 2015MalfunctionMindray Bio-medical Electronics Co Ltd2221819-2015-00058
- GAS MODULE IIIFeb 6, 2015MalfunctionMindray Bio-medical Electronics Co. Ltd.2221819-2014-01140
- GAS MODULE IIIFeb 6, 2015MalfunctionMindray Bio-medical Electronics Co. Ltd2221819-2015-00023
- GAS MODULE 2Feb 6, 2015MalfunctionMindray Bio-medical Electronics Co. Ltd.2221819-2015-00104
Event type breakdown
Recalls
3 recall events for this product code
- Respironics Novametrix, LLC.TerminatedSep 30, 2011
PHILIPS NM3 Monitor Model Number: 7900
Pressure lines maybe occluded and display incorrect tidal volumes.
Z-3287-2011 · View FDA record ↗ - Respironics Novametrix, LLC.TerminatedSep 30, 2011
FloTrak Elite modules
Pressure lines maybe occluded and display incorrect tidal volumes.
Z-3288-2011 · View FDA record ↗ - Mindray DS USA, Inc. dba Mindray North AmericaTerminatedUnknown
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Z-1242-2018 · View FDA record ↗
Registered firms
84 firms currently registered for this product code
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Ambulatory Monitoring, Inc.
ARDSLEY, NY, US
Ge Medical Systems Information Technologies
EL PASO, TX, US
Anesthesia Associates, Inc.
SAN MARCOS, CA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Raumedic Estonia As
Tallinn Harjumaa, EE
Galemed Corp.
WU-JIA Yilan, TW
Edan Diagnostics, Inc.
San Diego, CA, US
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Caf Medical Solutions Inc
Hockley, TX, US
Cbr Enterprise Limited
Hong Kong, HK
Ge Medical Systems Information Technologies - Critikon De Mexico S. De R.l. De C.v.
JUAREZ Chihuahua, MX
Vincent Medical Manufacturing. Co., Ltd.
KOWLOON, HK
Technical Services For Electronics, Inc.
New Taipei City, TW
510(k) clearances
61 clearances for this product code
- Mermaid Care A/SDec 18, 2019
K192584 · BEACON Caresystem Model 00002144
- Respiratory MotionDec 17, 2019
K192595 · ExSpiron 2Xi
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Oct 24, 2018
K180788 · Gas Module 3
- Respiratory Motion, Inc.Mar 16, 2018
K173181 · ExSpiron 1Xi
- Respiratory Motion, Inc.May 9, 2017
K162131 · ExSpiron 1Xi
- Respiratory Motion, Inc.May 29, 2013
K130170 · EXSPIRON 1XI
- Respiratory Motion, Inc.Sep 26, 2012
K120087 · EXSPIRON
- Respironics Novametrix, LLCJun 2, 2011
K103578 · PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST