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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
1. K182362
MaxCap Ped and MaxCap Neo
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
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
212
212
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3143
3143
Communication or Transmission Problem
2134
2134
Crack
2131
2131
Appropriate Term/Code Not Available
943
943
Corroded
875
875
Failure to Calibrate
784
784
Incorrect, Inadequate or Imprecise Result or Readings
700
700
Computer Software Problem
564
564
Device Alarm System
539
539
Contamination
498
498
Failure of Device to Self-Test
465
465
No Device Output
451
451
No Apparent Adverse Event
406
406
Loose or Intermittent Connection
372
372
Calibration Problem
336
336
Circuit Failure
295
295
Insufficient Information
292
292
Output Problem
201
201
Device Sensing Problem
176
176
Physical Resistance/Sticking
115
115
Failure to Read Input Signal
105
105
Display Difficult to Read
74
74
Display or Visual Feedback Problem
70
70
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
36
36
Incorrect Measurement
34
34
Low Readings
29
29
High Readings
28
28
Naturally Worn
27
27
Degraded
27
27
Application Program Problem
26
26
Failure to Cycle
25
25
Electrical /Electronic Property Problem
22
22
Power Problem
22
22
Gas Output Problem
18
18
Image Display Error/Artifact
17
17
Temperature Problem
17
17
Mechanical Problem
15
15
Erratic or Intermittent Display
13
13
No Display/Image
12
12
False Alarm
12
12
Device Markings/Labelling Problem
12
12
Noise, Audible
10
10
Defective Device
9
9
Defective Alarm
9
9
Use of Device Problem
9
9
Device Displays Incorrect Message
8
8
Obstruction of Flow
8
8
Device Ingredient or Reagent Problem
8
8
Mechanics Altered
8
8
Unexpected Shutdown
8
8
Application Program Version or Upgrade Problem
7
7
Battery Problem
7
7
Component Missing
7
7
Device Damaged Prior to Use
6
6
Material Deformation
6
6
Material Split, Cut or Torn
6
6
Suction Failure
5
5
Inaccurate Information
5
5
Data Problem
5
5
Charging Problem
5
5
Failure to Align
5
5
Defective Component
5
5
Failure to Sense
5
5
Sensing Intermittently
4
4
No Audible Prompt/Feedback
4
4
Inaccurate Delivery
4
4
Electrical Power Problem
4
4
Filtration Problem
4
4
Deformation Due to Compressive Stress
4
4
Protective Measures Problem
4
4
Component Misassembled
4
4
Material Integrity Problem
4
4
Infusion or Flow Problem
4
4
Moisture or Humidity Problem
3
3
Pressure Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Unclear Information
3
3
Missing Information
3
3
Intermittent Loss of Power
3
3
Detachment of Device or Device Component
3
3
Computer Operating System Problem
3
3
Gas/Air Leak
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
Inaccurate Flow Rate
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5896
5896
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
Cough
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Patient Problem/Medical Problem
1
1
Superficial (First Degree) Burn
1
1
Anxiety
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
Lethargy
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoxia
1
1
Laceration(s)
1
1
Pain
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
Southmedic, Inc.
II
Jul-24-2021
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