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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
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
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
1069
1069
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1461
1461
Crack
1375
1375
Communication or Transmission Problem
1041
1041
Appropriate Term/Code Not Available
939
939
Failure to Calibrate
583
583
Incorrect, Inadequate or Imprecise Resultor Readings
486
486
Contamination
483
483
Corroded
450
450
Failure of Device to Self-Test
447
447
No Apparent Adverse Event
367
367
No Device Output
364
364
Computer Software Problem
334
334
Device Alarm System
333
333
Circuit Failure
238
238
Insufficient Information
216
216
Output Problem
189
189
Device Sensing Problem
182
182
Loose or Intermittent Connection
176
176
Calibration Problem
149
149
Failure to Read Input Signal
100
100
Display or Visual Feedback Problem
66
66
Application Program Freezes, Becomes Nonfunctional
55
55
Misassembled
49
49
Physical Resistance/Sticking
39
39
Pumping Stopped
36
36
Unable to Obtain Readings
36
36
Display Difficult to Read
32
32
Incorrect Measurement
32
32
Peeled/Delaminated
30
30
Failure to Power Up
29
29
Failure to Cycle
25
25
Degraded
24
24
Naturally Worn
23
23
Application Program Problem
22
22
Low Readings
19
19
Electrical /Electronic Property Problem
18
18
High Readings
17
17
Power Problem
17
17
Device Operates Differently Than Expected
16
16
Gas Output Problem
16
16
Temperature Problem
12
12
Device Displays Incorrect Message
12
12
Image Display Error/Artifact
11
11
No Audible Alarm
11
11
Device Stops Intermittently
10
10
Device Markings/Labelling Problem
10
10
Use of Device Problem
9
9
Erratic or Intermittent Display
9
9
Mechanics Altered
8
8
Application Program Version or Upgrade Problem
7
7
Failure to Deliver
7
7
Mechanical Problem
7
7
False Alarm
7
7
Defective Alarm
6
6
Device Inoperable
6
6
Material Deformation
6
6
Material Integrity Problem
5
5
Device Operational Issue
5
5
Invalid Sensing
5
5
Component Missing
5
5
Device Issue
5
5
Defective Device
5
5
Charging Problem
5
5
Failure to Sense
5
5
Smoking
5
5
Partial Blockage
5
5
No Display/Image
5
5
Noise, Audible
5
5
Protective Measures Problem
4
4
Unexpected Shutdown
4
4
Sensing Intermittently
4
4
Nonstandard Device
4
4
Deformation Due to Compressive Stress
4
4
Detachment of Device or Device Component
4
4
Battery Problem
4
4
Device Damaged Prior to Use
4
4
Defective Component
4
4
Electrical Power Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Moisture or Humidity Problem
3
3
Data Problem
3
3
Filtration Problem
3
3
Gas Leak
3
3
Human-Device Interface Problem
3
3
Obstruction of Flow
3
3
Sparking
3
3
Computer Operating System Problem
3
3
Device Emits Odor
3
3
Overheating of Device
3
3
Failure to Analyze Signal
3
3
Disconnection
3
3
Material Fragmentation
3
3
Intermittent Communication Failure
3
3
Inaccurate Information
3
3
Intermittent Loss of Power
3
3
Material Split, Cut or Torn
2
2
Key or Button Unresponsive/not Working
2
2
Fluid Leak
2
2
Excess Flow or Over-Infusion
2
2
Application Program Problem: Dose Calculation Error
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
3003
3003
No Clinical Signs, Symptoms or Conditions
2665
2665
No Known Impact Or Consequence To Patient
147
147
No Consequences Or Impact To Patient
143
143
No Information
88
88
Insufficient Information
74
74
Low Oxygen Saturation
3
3
Death
2
2
Hypoxia
2
2
Respiratory Distress
2
2
Foreign Body In Patient
2
2
Patient Problem/Medical Problem
1
1
Partial thickness (Second Degree) Burn
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Laceration(s)
1
1
Pain
1
1
Perforation
1
1
Cardiac Arrest
1
1
Cardiopulmonary Arrest
1
1
Chest Pain
1
1
Cyanosis
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
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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