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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
1. K192563
Altera gas Sampling Lines
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
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
910
910
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2636
2636
Communication or Transmission Problem
1768
1768
Crack
1557
1557
Appropriate Term/Code Not Available
943
943
Corroded
765
765
Failure to Calibrate
714
714
Incorrect, Inadequate or Imprecise Result or Readings
619
619
Contamination
489
489
Device Alarm System
485
485
Failure of Device to Self-Test
455
455
Computer Software Problem
440
440
No Device Output
410
410
No Apparent Adverse Event
395
395
Insufficient Information
292
292
Calibration Problem
286
286
Circuit Failure
278
278
Loose or Intermittent Connection
258
258
Output Problem
211
211
Device Sensing Problem
184
184
Failure to Read Input Signal
105
105
Physical Resistance/Sticking
98
98
Display Difficult to Read
72
72
Display or Visual Feedback Problem
71
71
Application Program Freezes, Becomes Nonfunctional
60
60
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
21
21
Temperature Problem
18
18
Gas Output Problem
18
18
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
No Display/Image
10
10
Failure to Sense
10
10
Device Stops Intermittently
10
10
Defective Device
10
10
Use of Device Problem
10
10
Noise, Audible
10
10
Defective Alarm
9
9
Obstruction of Flow
8
8
Mechanics Altered
8
8
Unexpected Shutdown
8
8
Device Ingredient or Reagent Problem
7
7
Component Missing
7
7
Failure to Deliver
7
7
Application Program Version or Upgrade Problem
7
7
Battery Problem
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
Adverse Event Without Identified Device or Use Problem
5
5
Charging Problem
5
5
Device Operational Issue
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
Failure to Align
4
4
Deformation Due to Compressive Stress
4
4
Detachment of Device or Device Component
4
4
Electrical Power Problem
4
4
Infusion or Flow Problem
4
4
Filtration 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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4983
4983
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
85
85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Unintended Extubation
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
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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