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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
1. K213518
CARESCAPE CO2 Microstream parameter
2. K213911
Microstream CO2 NanoPod
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
1. K213518
CARESCAPE CO2 Microstream parameter
2. K213911
Microstream CO2 NanoPod
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
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
386
386
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3196
3196
Communication or Transmission Problem
2222
2222
Crack
2177
2177
Appropriate Term/Code Not Available
944
944
Corroded
891
891
Failure to Calibrate
809
809
Incorrect, Inadequate or Imprecise Result or Readings
710
710
Computer Software Problem
564
564
Device Alarm System
551
551
Contamination
507
507
Failure of Device to Self-Test
467
467
No Device Output
456
456
No Apparent Adverse Event
409
409
Loose or Intermittent Connection
394
394
Calibration Problem
341
341
Circuit Failure
298
298
Insufficient Information
294
294
Output Problem
204
204
Device Sensing Problem
176
176
Physical Resistance/Sticking
115
115
Failure to Read Input Signal
107
107
Display Difficult to Read
76
76
Display or Visual Feedback Problem
71
71
Application Program Freezes, Becomes Nonfunctional
61
61
Misassembled
48
48
Unable to Obtain Readings
46
46
Pumping Stopped
37
37
Peeled/Delaminated
37
37
Failure to Power Up
37
37
Incorrect Measurement
34
34
High Readings
30
30
Low Readings
30
30
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
No Display/Image
14
14
Erratic or Intermittent Display
13
13
False Alarm
12
12
Noise, Audible
11
11
Unexpected Shutdown
10
10
Defective Device
10
10
Defective Alarm
9
9
Use of Device Problem
9
9
Defective Component
8
8
Device Displays Incorrect Message
8
8
Obstruction of Flow
8
8
Device Ingredient or Reagent Problem
8
8
Mechanics Altered
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
Failure to Sense
5
5
Inaccurate Delivery
4
4
Sensing Intermittently
4
4
No Audible Prompt/Feedback
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
Complete Loss of Power
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
Failure to Analyze Signal
3
3
No Audible Alarm
3
3
Partial Blockage
3
3
Material Fragmentation
3
3
Unintended Application Program Shut Down
3
3
Intermittent Communication Failure
3
3
Excess Flow or Over-Infusion
2
2
Leak/Splash
2
2
Inaccurate Flow Rate
2
2
Fluid/Blood Leak
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6064
6064
No Patient Involvement
2984
2984
No Consequences Or Impact To Patient
117
117
Insufficient Information
108
108
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
Discomfort
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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