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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
1. K203762
Nellcor EASYCAP II Adult Colorimetric CO2 Detector
...
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
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
1637
1637
2024
474
474
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3229
3229
Communication or Transmission Problem
2277
2277
Crack
2200
2200
Appropriate Term/Code Not Available
944
944
Corroded
904
904
Failure to Calibrate
823
823
Incorrect, Inadequate or Imprecise Result or Readings
734
734
Computer Software Problem
564
564
Device Alarm System
556
556
Contamination
509
509
Failure of Device to Self-Test
469
469
No Device Output
457
457
No Apparent Adverse Event
409
409
Loose or Intermittent Connection
396
396
Calibration Problem
350
350
Circuit Failure
298
298
Insufficient Information
295
295
Output Problem
220
220
Device Sensing Problem
184
184
Physical Resistance/Sticking
115
115
Failure to Read Input Signal
107
107
Display Difficult to Read
77
77
Display or Visual Feedback Problem
73
73
Application Program Freezes, Becomes Nonfunctional
61
61
Unable to Obtain Readings
55
55
Misassembled
49
49
Incorrect Measurement
41
41
Failure to Power Up
37
37
Peeled/Delaminated
37
37
Pumping Stopped
37
37
High Readings
32
32
Low Readings
32
32
Naturally Worn
28
28
Degraded
27
27
Application Program Problem
26
26
Failure to Cycle
25
25
Electrical /Electronic Property Problem
24
24
Power Problem
22
22
Gas Output Problem
19
19
Mechanical Problem
19
19
Temperature Problem
18
18
Image Display Error/Artifact
17
17
Device Operates Differently Than Expected
16
16
Device Markings/Labelling Problem
15
15
No Display/Image
15
15
Erratic or Intermittent Display
13
13
Device Displays Incorrect Message
13
13
Use of Device Problem
12
12
False Alarm
12
12
No Audible Alarm
12
12
Noise, Audible
12
12
Unexpected Shutdown
12
12
Failure to Sense
11
11
Defective Device
11
11
Device Stops Intermittently
10
10
Device Ingredient or Reagent Problem
10
10
Defective Alarm
10
10
Defective Component
9
9
Obstruction of Flow
9
9
Mechanics Altered
8
8
Application Program Version or Upgrade Problem
7
7
Battery Problem
7
7
Component Missing
7
7
Failure to Deliver
7
7
Device Damaged Prior to Use
6
6
Device Inoperable
6
6
Material Deformation
6
6
Material Integrity Problem
6
6
Smoking
6
6
Material Split, Cut or Torn
6
6
Data Problem
5
5
Suction Failure
5
5
Inaccurate Information
5
5
Partial Blockage
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Device Operational Issue
5
5
Device Issue
5
5
Invalid Sensing
5
5
Charging Problem
5
5
Failure to Align
5
5
Inaccurate Delivery
4
4
No Audible Prompt/Feedback
4
4
Electrical Power Problem
4
4
Filtration Problem
4
4
Deformation Due to Compressive Stress
4
4
Detachment of Device or Device Component
4
4
Infusion or Flow Problem
4
4
Disconnection
4
4
Sensing Intermittently
4
4
Nonstandard Device
4
4
Intermittent Loss of Power
4
4
Protective Measures Problem
4
4
Component Misassembled
4
4
Complete Loss of Power
3
3
Pressure Problem
3
3
Unclear Information
3
3
Missing Information
3
3
Unintended Application Program Shut Down
3
3
Intermittent Communication Failure
3
3
Material Fragmentation
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6151
6151
No Patient Involvement
3000
3000
No Known Impact Or Consequence To Patient
146
146
No Consequences Or Impact To Patient
143
143
Insufficient Information
109
109
No Information
88
88
Unintended Extubation
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Unspecified Tissue Injury
4
4
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
Partial thickness (Second Degree) Burn
1
1
Patient Problem/Medical Problem
1
1
Superficial (First Degree) Burn
1
1
Cough
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Death, Intrauterine Fetal
1
1
Hypersensitivity/Allergic reaction
1
1
Burn, Thermal
1
1
Lethargy
1
1
Pressure Sores
1
1
Anxiety
1
1
Discomfort
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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