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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
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
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
2
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
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
3
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
SOUTHMEDIC INC.
SUBSTANTIALLY EQUIVALENT
1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
1. K181981
CO2 Sampling Line
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
141
141
2020
2302
2302
2021
2272
2272
2022
2475
2475
2023
1637
1637
2024
289
289
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3163
3163
Communication or Transmission Problem
2180
2180
Crack
2149
2149
Appropriate Term/Code Not Available
943
943
Corroded
884
884
Failure to Calibrate
795
795
Incorrect, Inadequate or Imprecise Result or Readings
701
701
Computer Software Problem
564
564
Device Alarm System
546
546
Contamination
505
505
Failure of Device to Self-Test
466
466
No Device Output
452
452
No Apparent Adverse Event
408
408
Loose or Intermittent Connection
382
382
Calibration Problem
338
338
Circuit Failure
298
298
Insufficient Information
292
292
Output Problem
202
202
Device Sensing Problem
176
176
Physical Resistance/Sticking
115
115
Failure to Read Input Signal
105
105
Display Difficult to Read
75
75
Display or Visual Feedback Problem
71
71
Application Program Freezes, Becomes Nonfunctional
61
61
Misassembled
48
48
Unable to Obtain Readings
41
41
Failure to Power Up
37
37
Pumping Stopped
37
37
Peeled/Delaminated
37
37
Incorrect Measurement
34
34
High Readings
30
30
Low Readings
29
29
Naturally Worn
27
27
Degraded
27
27
Application Program Problem
26
26
Failure to Cycle
25
25
Electrical /Electronic Property Problem
23
23
Power Problem
22
22
Gas Output Problem
18
18
Image Display Error/Artifact
17
17
Temperature Problem
17
17
Device Markings/Labelling Problem
15
15
Mechanical Problem
15
15
Erratic or Intermittent Display
13
13
No Display/Image
13
13
False Alarm
12
12
Noise, Audible
11
11
Defective Device
9
9
Defective Alarm
9
9
Use of Device Problem
9
9
Obstruction of Flow
8
8
Device Displays Incorrect Message
8
8
Device Ingredient or Reagent Problem
8
8
Unexpected Shutdown
8
8
Mechanics Altered
8
8
Application Program Version or Upgrade Problem
7
7
Battery Problem
7
7
Defective Component
7
7
Component Missing
7
7
Device Damaged Prior to Use
6
6
Material Deformation
6
6
Material Split, Cut or Torn
6
6
Data Problem
5
5
Suction Failure
5
5
Inaccurate Information
5
5
Charging Problem
5
5
Failure to Align
5
5
Failure to Sense
5
5
Sensing Intermittently
4
4
No Audible Prompt/Feedback
4
4
Inaccurate Delivery
4
4
Deformation Due to Compressive Stress
4
4
Electrical Power Problem
4
4
Infusion or Flow Problem
4
4
Filtration Problem
4
4
Component Misassembled
4
4
Material Integrity Problem
4
4
Protective Measures Problem
4
4
Pressure Problem
3
3
Moisture or Humidity Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Unclear Information
3
3
Missing Information
3
3
Complete Loss of Power
3
3
Intermittent Loss of Power
3
3
Gas/Air Leak
3
3
Detachment of Device or Device Component
3
3
Computer Operating System Problem
3
3
Sparking
3
3
Nonstandard Device
3
3
Material Fragmentation
3
3
Failure to Analyze Signal
3
3
No Audible Alarm
3
3
Partial Blockage
3
3
Unintended Application Program Shut Down
3
3
Intermittent Communication Failure
3
3
Complete Blockage
2
2
Thermal Decomposition of Device
2
2
Failure to Charge
2
2
Disconnection
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5973
5973
No Patient Involvement
2984
2984
No Consequences Or Impact To Patient
117
117
Insufficient Information
103
103
No Information
81
81
No Known Impact Or Consequence To Patient
76
76
Unintended Extubation
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Cardiac Arrest
3
3
Death
2
2
Foreign Body In Patient
2
2
Unspecified Tissue Injury
2
2
Respiratory Arrest
1
1
Cyanosis
1
1
Extubate
1
1
Lethargy
1
1
Superficial (First Degree) Burn
1
1
Cough
1
1
Anxiety
1
1
Laceration(s)
1
1
Chest Pain
1
1
Pain
1
1
Cardiopulmonary Arrest
1
1
Hypersensitivity/Allergic reaction
1
1
Respiratory Insufficiency
1
1
Hypoxia
1
1
Patient Problem/Medical Problem
1
1
Inadequate Pain Relief
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
Southmedic, Inc.
II
Jul-24-2021
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