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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Description Carbon dioxide gas analyzer.
Product CodeCCK
Regulation Number 868.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
AFFIRM MEDICAL TECHNOLOGIES II, LLC
  SUBSTANTIALLY EQUIVALENT 1
BARBARAS DEVELOPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K251216  0184 CO2 Sampling line; 0184T CO2 Sampling line; 0 ...
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 3
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
ENDURE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXOSTAT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 2
INVENTEUR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDIPINES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDITERA TIBBI MALZEME SAN VE TIC AS
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORANTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 , LTD.
  SUBSTANTIALLY EQUIVALENT 3
PNEUMA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRIOR CARE SCIENCE TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRION, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYLENOL MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 63 63
2019 141 141
2020 2302 2302
2021 2272 2293
2022 2475 2475
2023 1637 1640
2024 1216 1216
2025 1274 1274
2026 782 782

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3538 3538
Communication or Transmission Problem 3397 3397
Crack 2685 2685
Failure to Calibrate 1110 1110
Corroded 1105 1106
Appropriate Device Problem Term/Code Not Available 930 930
Device Alarm System 909 909
Incorrect, Inadequate or Imprecise Result or Readings 768 768
Calibration Problem 719 720
No Device Output 557 557
Computer Software Problem 556 556
Contamination 538 538
Failure of Device to Self-Test 510 511
Loose or Intermittent Connection 465 465
No Apparent Adverse Event 426 426
Circuit Failure 311 311
Output Problem 285 285
Insufficient Device Problem Information 282 282
Device Sensing Problem 176 176
Unable to Obtain Readings 152 152
Physical Resistance/Sticking 139 139
Missing Information 125 125
Display or Visual Feedback Problem 114 114
Failure to Read Input Signal 107 107
Incorrect Measurement 80 80
Display Difficult to Read 78 78
Low Readings 74 74
Inadequate or Insufficient Training 71 71
Application Program Freezes or Fails to Launch 62 62
Gas Output Problem 56 56
Image Display Error/Artifact 54 54
High Readings 54 54
Misassembled 51 51
Pumping Stopped 41 41
Failure to Power Up 40 40
Peeled/Delaminated 38 38
Application Program Problem 33 33
Electrical /Electronic Property Problem 29 29
Naturally Worn 28 28
Degraded 27 27
Power Problem 25 25
Failure to Cycle 24 24
No Display/Image 24 24
Temperature Problem 23 23
Mechanical Problem 21 21
Failure to Analyze Signal 18 18
Noise, Audible 18 18
Device Markings/Labelling Problem 16 16
Use of Device Problem 16 17
Unexpected Shutdown 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8889 8911
No Patient Involvement 2990 2990
Insufficient Information 156 158
No Consequences Or Impact To Patient 132 132
No Known Impact Or Consequence To Patient 114 114
No Information 81 81
Unintended Extubation 15 15
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 9 9
Low Oxygen Saturation 7 7
Cardiac Arrest 5 5
Unspecified Tissue Injury 4 4
Foreign Body In Patient 3 3
Death 2 2
Respiratory Distress 2 2
Laceration(s) 2 2
Pain 2 2
Hypoxia 2 2
Respiratory Failure 2 2
Cyanosis 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoventilation 1 1
Respiratory Arrest 1 1
Perforation 1 1
Burn(s) 1 1
Injury 1 1
Chest Pain 1 1
Discomfort 1 1
Cardiopulmonary Arrest 1 1
Pressure Sore/Ulcer 1 1
Eye Injury 1 1
Anxiety 1 1
Cough 1 1
Bacterial Infection 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Respiratory Insufficiency 1 1
Bruise/Contusion 1 1
Lethargy 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 Nihon Kohden America Inc II Nov-06-2024
5 Oridion Medical 1987 Ltd. II Mar-17-2025
6 Oridion Medical 1987 Ltd. II Oct-03-2018
7 Philips North America Llc II May-05-2025
8 Smiths Medical ASD Inc. II Jul-06-2018
9 Smiths Medical ASD, Inc. II Mar-20-2025
10 Southmedic, Inc. II Jul-24-2021
11 Southmedic, Inc. II Jan-25-2018
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