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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
CMI HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
1. K213518
CARESCAPE CO2 Microstream parameter
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
1
1. K213518
CARESCAPE CO2 Microstream parameter
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
1412
1412
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1632
1632
Crack
1387
1387
Communication or Transmission Problem
1199
1199
Appropriate Term/Code Not Available
940
940
Failure to Calibrate
605
605
Corroded
509
509
Incorrect, Inadequate or Imprecise Resultor Readings
491
491
Contamination
485
485
Failure of Device to Self-Test
449
449
No Device Output
378
378
No Apparent Adverse Event
370
370
Device Alarm System
360
360
Computer Software Problem
334
334
Insufficient Information
259
259
Circuit Failure
248
248
Output Problem
191
191
Loose or Intermittent Connection
187
187
Device Sensing Problem
182
182
Calibration Problem
166
166
Failure to Read Input Signal
102
102
Display or Visual Feedback Problem
67
67
Application Program Freezes, Becomes Nonfunctional
56
56
Misassembled
49
49
Physical Resistance/Sticking
43
43
Unable to Obtain Readings
37
37
Pumping Stopped
36
36
Display Difficult to Read
35
35
Incorrect Measurement
33
33
Peeled/Delaminated
31
31
Failure to Power Up
30
30
Failure to Cycle
25
25
Degraded
24
24
Naturally Worn
23
23
Application Program Problem
22
22
Electrical /Electronic Property Problem
20
20
Low Readings
19
19
High Readings
18
18
Power Problem
17
17
Device Operates Differently Than Expected
16
16
Gas Output Problem
16
16
Temperature Problem
13
13
Device Displays Incorrect Message
12
12
No Audible Alarm
12
12
Image Display Error/Artifact
11
11
Device Markings/Labelling Problem
11
11
Device Stops Intermittently
10
10
Use of Device Problem
10
10
Erratic or Intermittent Display
9
9
False Alarm
8
8
Mechanics Altered
8
8
Application Program Version or Upgrade Problem
7
7
Failure to Deliver
7
7
Mechanical Problem
7
7
Defective Alarm
6
6
Device Inoperable
6
6
Smoking
6
6
Material Deformation
6
6
Noise, Audible
6
6
Material Integrity Problem
5
5
Device Operational Issue
5
5
Invalid Sensing
5
5
Component Missing
5
5
Device Damaged Prior to Use
5
5
Device Issue
5
5
Defective Device
5
5
Charging Problem
5
5
Failure to Sense
5
5
Partial Blockage
5
5
No Display/Image
5
5
Sensing Intermittently
4
4
Nonstandard Device
4
4
Detachment of Device or Device Component
4
4
Battery Problem
4
4
Defective Component
4
4
Deformation Due to Compressive Stress
4
4
Electrical Power Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Protective Measures Problem
4
4
Unexpected Shutdown
4
4
Intermittent Loss of Power
3
3
Data Problem
3
3
Intermittent Communication Failure
3
3
Inaccurate Information
3
3
Moisture or Humidity 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
Fluid Leak
2
2
Excess Flow or Over-Infusion
2
2
Application Program Problem: Dose Calculation Error
2
2
Failure to Charge
2
2
Self-Activation or Keying
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3013
3013
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
74
74
Low Oxygen Saturation
3
3
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
Cardiac Arrest
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
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
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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