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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
ENDURE INDUSTRIES INC
SUBSTANTIALLY EQUIVALENT
1
1. K213767
Endure ETCO2/02 Nasal Cannula
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
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
1490
1490
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2943
2943
Crack
2000
2000
Communication or Transmission Problem
1948
1948
Appropriate Term/Code Not Available
943
943
Corroded
847
847
Failure to Calibrate
747
747
Incorrect, Inadequate or Imprecise Result or Readings
688
688
Computer Software Problem
553
553
Device Alarm System
504
504
Contamination
492
492
Failure of Device to Self-Test
460
460
No Device Output
437
437
No Apparent Adverse Event
400
400
Loose or Intermittent Connection
349
349
Calibration Problem
317
317
Insufficient Information
293
293
Circuit Failure
283
283
Output Problem
215
215
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
Device Operates Differently Than Expected
16
16
Image Display Error/Artifact
15
15
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
Failure to Sense
10
10
Defective Alarm
10
10
Defective Device
10
10
Device Stops Intermittently
10
10
Noise, Audible
10
10
Unexpected Shutdown
9
9
Obstruction of Flow
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
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
Suction Failure
5
5
Inaccurate Information
5
5
Protective Measures Problem
4
4
Intermittent Loss of Power
4
4
Data Problem
4
4
Component Misassembled
4
4
Disconnection
4
4
Sensing Intermittently
4
4
Nonstandard Device
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
Gas/Air Leak
3
3
Human-Device Interface Problem
3
3
Inappropriate or Unexpected Reset
3
3
Moisture or Humidity Problem
3
3
Pressure Problem
3
3
Sparking
3
3
Computer Operating System Problem
3
3
Inaccurate Delivery
3
3
No Audible Prompt/Feedback
3
3
Device Emits Odor
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5553
5553
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
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