Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Anesthesiology · 21 CFR 868.1700
Recent MDR events
21 adverse event reports on file
- HAMILTON T1Feb 7, 2025MalfunctionHamilton Medical Ag3001421318-2025-00247
- SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESJan 6, 2020MalfunctionSpacelabs Medical Inc.3007409280-2020-00001
- SPACELABS MULTIGAS MODULEJan 2, 2015MalfunctionSpacelabs Healthcare Inc.3010157426-2014-00081
- SPACELABS MULTIGAS MODULEJul 8, 2013MalfunctionSpacelabs Medical Inc.3023361-2013-00029
- SPACELABS MULTIGAS ANALYZER MODULEMay 8, 2012MalfunctionSpacelabs Medical Inc.3023361-2012-00019
- SPACELABS MULTIGAS ANALYZER MODULEMay 8, 2012MalfunctionSpacelabs Medical Inc.3023361-2012-00021
- SPACELABS MULTIGAS ANALYZER MODULEMay 8, 2012MalfunctionSpacelabs Medical Inc.3023361-2012-00020
- SPACELABS MULTIGAS ANALYZER MODULE 91518Apr 16, 2012MalfunctionSpacelabs Medical Inc.,3023361-2012-00015
- SPACELABS MULTIGAS ANALYSER MODULEApr 13, 2012MalfunctionSpacelabs Medical Inc.3023361-2012-00014
- SPACELABS MULTIGAS ANALYZER MODULEApr 13, 2012MalfunctionSpacelabs Medical Inc.3023361-2012-00017
Event type breakdown
Recalls
3 recall events for this product code
- Spacelabs Healthcare IncTerminatedJul 17, 2014
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Z-2077-2014 · View FDA record ↗ - Spacelabs Healthcare, LlcTerminatedAug 1, 2011
Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14.
Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.
Z-2902-2011 · View FDA record ↗ - Spacelabs Healthcare, IncorporatedTerminatedJan 31, 2008
Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027
Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.
Z-0660-2008 · View FDA record ↗
Registered firms
159 firms currently registered for this product code
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Masimo Corporation
Irvine, CA, US
Raumedic Estonia As
Tallinn Harjumaa, EE
Edan Diagnostics, Inc.
San Diego, CA, US
Philips North America Llc
Export, PA, US
Philips North America Llc
Murrysville, PA, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Philips Electronics Ltd
Mississauga Ontario, CA
Industrial Vallera De Mexicali, S. A. De C. V.
Mexicali Mexico, MX
Technical Services For Electronics, Inc.
New Taipei City, TW
Dre Med
Louisville, KY, US
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Caf Medical Solutions Inc
Hockley, TX, US
Cbr Enterprise Limited
Hong Kong, HK
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
510(k) clearances
5 clearances for this product code
- Spacelabs HealthcareOct 5, 2011
K112173 · SPEACELABS MULTIGAS MODULE
- Spacelabs Medical, Inc.Apr 19, 2006
K053599 · SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
- Spacelabs, Inc.May 31, 1996
K954962 · SPACELABS MEDICAL MULTIGAS ANALYZER
- Dalton Instrument Corp.Apr 9, 1991
K904843 · OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
- Erich Jaeger, Inc.Sep 3, 1985
K853360 · N20 TEST