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TPLC
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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
1. K190824
Airway Gas Sampling Set, disposable, Adult/Pediatr
...
CMI HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
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
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
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
2306
2306
2021
2272
2272
2022
2476
2476
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2086
2086
Communication or Transmission Problem
1558
1558
Crack
1431
1431
Appropriate Term/Code Not Available
940
940
Failure to Calibrate
670
670
Corroded
669
669
Incorrect, Inadequate or Imprecise Result or Readings
555
555
Contamination
486
486
Device Alarm System
452
452
Failure of Device to Self-Test
451
451
No Device Output
389
389
No Apparent Adverse Event
379
379
Computer Software Problem
342
342
Insufficient Information
274
274
Circuit Failure
270
270
Calibration Problem
238
238
Loose or Intermittent Connection
218
218
Output Problem
202
202
Device Sensing Problem
183
183
Failure to Read Input Signal
104
104
Physical Resistance/Sticking
78
78
Display or Visual Feedback Problem
70
70
Display Difficult to Read
57
57
Application Program Freezes, Becomes Nonfunctional
56
56
Misassembled
49
49
Unable to Obtain Readings
44
44
Incorrect Measurement
38
38
Pumping Stopped
36
36
Failure to Power Up
35
35
Peeled/Delaminated
33
33
Application Program Problem
25
25
Failure to Cycle
25
25
Degraded
25
25
Naturally Worn
25
25
High Readings
24
24
Low Readings
22
22
Electrical /Electronic Property Problem
21
21
Power Problem
20
20
Gas Output Problem
18
18
Device Operates Differently Than Expected
16
16
Image Display Error/Artifact
15
15
Temperature Problem
15
15
Mechanical Problem
13
13
No Audible Alarm
12
12
Device Displays Incorrect Message
12
12
Device Markings/Labelling Problem
11
11
Erratic or Intermittent Display
11
11
Use of Device Problem
10
10
Defective Device
10
10
Noise, Audible
10
10
False Alarm
10
10
Device Stops Intermittently
10
10
Failure to Sense
8
8
No Display/Image
8
8
Mechanics Altered
8
8
Defective Alarm
7
7
Obstruction of Flow
7
7
Failure to Deliver
7
7
Application Program Version or Upgrade Problem
7
7
Unexpected Shutdown
7
7
Battery Problem
7
7
Defective Component
6
6
Material Deformation
6
6
Material Integrity Problem
6
6
Device Inoperable
6
6
Component Missing
6
6
Smoking
6
6
Device Damaged Prior to Use
5
5
Invalid Sensing
5
5
Partial Blockage
5
5
Charging Problem
5
5
Inaccurate Information
5
5
Device Operational Issue
5
5
Device Issue
5
5
Infusion or Flow Problem
4
4
Intermittent Loss of Power
4
4
Protective Measures Problem
4
4
Device Ingredient or Reagent Problem
4
4
Data Problem
4
4
Sensing Intermittently
4
4
Electrical Power Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Deformation Due to Compressive Stress
4
4
Detachment of Device or Device Component
4
4
Filtration Problem
4
4
Nonstandard Device
4
4
Overheating of Device
3
3
Moisture or Humidity Problem
3
3
Intermittent Communication Failure
3
3
Component Misassembled
3
3
No Audible Prompt/Feedback
3
3
Failure to Analyze Signal
3
3
Disconnection
3
3
Pressure Problem
3
3
Computer Operating System Problem
3
3
Gas/Air Leak
3
3
Human-Device Interface Problem
3
3
Sparking
3
3
Material Fragmentation
3
3
Device Emits Odor
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4074
4074
No Patient Involvement
3003
3003
No Known Impact Or Consequence To Patient
147
147
No Consequences Or Impact To Patient
143
143
No Information
88
88
Insufficient Information
81
81
Cardiac Arrest
3
3
Low Oxygen Saturation
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Foreign Body In Patient
2
2
Death
2
2
Hypoxia
2
2
Unspecified Tissue Injury
2
2
Respiratory Distress
2
2
Injury
1
1
Burn, Thermal
1
1
Chest Pain
1
1
Laceration(s)
1
1
Pain
1
1
Pressure Sores
1
1
Lethargy
1
1
Superficial (First Degree) Burn
1
1
Partial thickness (Second Degree) Burn
1
1
Unintended Extubation
1
1
Cardiopulmonary Arrest
1
1
Perforation
1
1
Inadequate Pain Relief
1
1
Death, Intrauterine Fetal
1
1
Patient Problem/Medical Problem
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Cyanosis
1
1
Hypersensitivity/Allergic reaction
1
1
Extubate
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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