Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
analyzer, gas, carbon-dioxide, gaseous-phase
Product Code
CCK
Regulation Number
868.1400
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
SUBSTANTIALLY EQUIVALENT
2
BLUEPOINT MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
CMI HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
ENDURE INDUSTRIES INC
SUBSTANTIALLY EQUIVALENT
1
ENGINEERED MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
3
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDIPINES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
1. K180902
MediPines Gas Exchange Monitor (GEM), Accessory Mo
...
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
SUBSTANTIALLY EQUIVALENT
1
NIHON KOHDEN CORPORATION
SUBSTANTIALLY EQUIVALENT
2
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
3
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
1
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POM MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
RESPIRION, INC.
SUBSTANTIALLY EQUIVALENT
1
REVOLUTIONARY MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
SOUTHMEDIC INC.
SUBSTANTIALLY EQUIVALENT
1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VENTURE THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
58
58
2018
63
63
2019
141
141
2020
2302
2302
2021
2272
2272
2022
2475
2475
2023
1597
1597
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3006
3006
Crack
2046
2046
Communication or Transmission Problem
2010
2010
Appropriate Term/Code Not Available
943
943
Corroded
847
847
Failure to Calibrate
758
758
Incorrect, Inadequate or Imprecise Result or Readings
692
692
Computer Software Problem
564
564
Device Alarm System
515
515
Contamination
492
492
Failure of Device to Self-Test
461
461
No Device Output
441
441
No Apparent Adverse Event
404
404
Loose or Intermittent Connection
361
361
Calibration Problem
323
323
Insufficient Information
293
293
Circuit Failure
285
285
Output Problem
216
216
Device Sensing Problem
184
184
Physical Resistance/Sticking
111
111
Failure to Read Input Signal
105
105
Display Difficult to Read
75
75
Display or Visual Feedback Problem
72
72
Application Program Freezes, Becomes Nonfunctional
61
61
Misassembled
49
49
Unable to Obtain Readings
47
47
Incorrect Measurement
38
38
Peeled/Delaminated
36
36
Failure to Power Up
36
36
Pumping Stopped
36
36
Naturally Worn
28
28
Low Readings
28
28
Degraded
27
27
High Readings
26
26
Application Program Problem
26
26
Failure to Cycle
25
25
Electrical /Electronic Property Problem
22
22
Power Problem
22
22
Temperature Problem
18
18
Gas Output Problem
18
18
Image Display Error/Artifact
17
17
Device Operates Differently Than Expected
16
16
Mechanical Problem
15
15
Erratic or Intermittent Display
13
13
Device Displays Incorrect Message
13
13
Device Markings/Labelling Problem
12
12
False Alarm
12
12
No Audible Alarm
12
12
No Display/Image
11
11
Use of Device Problem
11
11
Noise, Audible
11
11
Failure to Sense
10
10
Defective Alarm
10
10
Defective Device
10
10
Device Stops Intermittently
10
10
Obstruction of Flow
9
9
Unexpected Shutdown
9
9
Device Ingredient or Reagent Problem
8
8
Mechanics Altered
8
8
Component Missing
7
7
Failure to Deliver
7
7
Application Program Version or Upgrade Problem
7
7
Battery Problem
7
7
Device Inoperable
6
6
Smoking
6
6
Defective Component
6
6
Material Deformation
6
6
Material Integrity Problem
6
6
Material Split, Cut or Torn
6
6
Suction Failure
5
5
Inaccurate Information
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Device Operational Issue
5
5
Invalid Sensing
5
5
Device Damaged Prior to Use
5
5
Device Issue
5
5
Failure to Align
5
5
Charging Problem
5
5
Partial Blockage
5
5
Disconnection
4
4
Sensing Intermittently
4
4
Nonstandard Device
4
4
Inaccurate Delivery
4
4
Electrical Power Problem
4
4
Deformation Due to Compressive Stress
4
4
Detachment of Device or Device Component
4
4
Infusion or Flow Problem
4
4
Filtration Problem
4
4
Intermittent Loss of Power
4
4
Protective Measures Problem
4
4
Component Misassembled
4
4
Data Problem
4
4
Intermittent Communication Failure
3
3
Missing Information
3
3
Gas/Air Leak
3
3
Human-Device Interface Problem
3
3
Inappropriate or Unexpected Reset
3
3
Pressure Problem
3
3
Moisture or Humidity Problem
3
3
No Audible Prompt/Feedback
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5660
5660
No Patient Involvement
3000
3000
No Known Impact Or Consequence To Patient
146
146
No Consequences Or Impact To Patient
143
143
Insufficient Information
94
94
No Information
88
88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Unintended Extubation
7
7
Foreign Body In Patient
3
3
Low Oxygen Saturation
3
3
Cardiac Arrest
3
3
Hypoxia
2
2
Death
2
2
Respiratory Distress
2
2
Unspecified Tissue Injury
2
2
Patient Problem/Medical Problem
1
1
Superficial (First Degree) Burn
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Partial thickness (Second Degree) Burn
1
1
Death, Intrauterine Fetal
1
1
Hypersensitivity/Allergic reaction
1
1
Burn, Thermal
1
1
Lethargy
1
1
Pressure Sores
1
1
Injury
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
Laceration(s)
1
1
Pain
1
1
Perforation
1
1
Cardiopulmonary Arrest
1
1
Chest Pain
1
1
Cyanosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CareFusion 303, Inc.
II
Aug-30-2019
2
Covidien Llc
II
Dec-01-2020
3
GE Healthcare, LLC
I
Jan-10-2020
4
Oridion Medical 1987 Ltd.
II
Oct-03-2018
5
Smiths Medical ASD Inc.
II
Jul-06-2018
6
Southmedic, Inc.
II
Jul-24-2021
7
Southmedic, Inc.
II
Jan-25-2018
-
-