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TPLC
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show TPLC since
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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
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
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
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
1. K181981
CO2 Sampling Line
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
2303
2303
2021
2272
2272
2022
2476
2476
2023
642
642
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2455
2455
Communication or Transmission Problem
1703
1703
Crack
1512
1512
Appropriate Term/Code Not Available
940
940
Corroded
745
745
Failure to Calibrate
708
708
Incorrect, Inadequate or Imprecise Result or Readings
605
605
Contamination
488
488
Device Alarm System
477
477
Failure of Device to Self-Test
455
455
Computer Software Problem
407
407
No Device Output
406
406
No Apparent Adverse Event
392
392
Insufficient Information
290
290
Calibration Problem
282
282
Circuit Failure
273
273
Loose or Intermittent Connection
244
244
Output Problem
211
211
Device Sensing Problem
184
184
Failure to Read Input Signal
105
105
Physical Resistance/Sticking
95
95
Display or Visual Feedback Problem
71
71
Display Difficult to Read
65
65
Application Program Freezes, Becomes Nonfunctional
59
59
Misassembled
49
49
Unable to Obtain Readings
46
46
Incorrect Measurement
39
39
Peeled/Delaminated
36
36
Failure to Power Up
36
36
Pumping Stopped
36
36
Degraded
27
27
Naturally Worn
27
27
Low Readings
27
27
Application Program Problem
25
25
High Readings
25
25
Failure to Cycle
25
25
Electrical /Electronic Property Problem
21
21
Power Problem
20
20
Gas Output Problem
18
18
Temperature Problem
17
17
Device Operates Differently Than Expected
16
16
Image Display Error/Artifact
15
15
Mechanical Problem
13
13
Device Displays Incorrect Message
13
13
Device Markings/Labelling Problem
12
12
False Alarm
12
12
No Audible Alarm
12
12
Erratic or Intermittent Display
11
11
Failure to Sense
10
10
Device Stops Intermittently
10
10
Defective Device
10
10
Use of Device Problem
10
10
Noise, Audible
10
10
No Display/Image
9
9
Defective Alarm
8
8
Mechanics Altered
8
8
Obstruction of Flow
7
7
Component Missing
7
7
Failure to Deliver
7
7
Application Program Version or Upgrade Problem
7
7
Battery Problem
7
7
Unexpected Shutdown
7
7
Defective Component
6
6
Material Deformation
6
6
Material Integrity Problem
6
6
Device Inoperable
6
6
Smoking
6
6
Partial Blockage
5
5
Device Operational Issue
5
5
Charging Problem
5
5
Invalid Sensing
5
5
Device Damaged Prior to Use
5
5
Device Issue
5
5
Inaccurate Information
5
5
Intermittent Loss of Power
4
4
Component Misassembled
4
4
Data Problem
4
4
Intermittent Communication Failure
4
4
Deformation Due to Compressive Stress
4
4
Detachment of Device or Device Component
4
4
Device Ingredient or Reagent Problem
4
4
Electrical Power Problem
4
4
Infusion or Flow Problem
4
4
Filtration Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Protective Measures Problem
4
4
Disconnection
4
4
Sensing Intermittently
4
4
Nonstandard Device
4
4
Material Fragmentation
3
3
Overheating of Device
3
3
Device Emits Odor
3
3
Failure to Analyze Signal
3
3
Pressure Problem
3
3
Moisture or Humidity Problem
3
3
Gas/Air Leak
3
3
Human-Device Interface Problem
3
3
Inappropriate or Unexpected Reset
3
3
Sparking
3
3
Computer Operating System Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4723
4723
No Patient Involvement
3000
3000
No Known Impact Or Consequence To Patient
147
147
No Consequences Or Impact To Patient
143
143
No Information
88
88
Insufficient Information
84
84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Low Oxygen Saturation
3
3
Cardiac Arrest
3
3
Hypoxia
2
2
Death
2
2
Unspecified Tissue Injury
2
2
Respiratory Distress
2
2
Foreign Body In Patient
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
Unintended Extubation
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
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