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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
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 2
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
  1.  K221118  CO2 Mainstream Sensor
ENDURE INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 3
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. 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
PNEUMA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POM MEDICAL, LLC
  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
VENTURE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 58 58
2018 63 63
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1638 1638
2024 1216 1216
2025 262 262

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3417 3417
Communication or Transmission Problem 2791 2791
Crack 2432 2432
Corroded 1022 1022
Failure to Calibrate 950 950
Appropriate Term/Code Not Available 945 945
Incorrect, Inadequate or Imprecise Result or Readings 738 738
Device Alarm System 664 664
Computer Software Problem 564 564
Contamination 530 530
Failure of Device to Self-Test 486 486
No Device Output 482 482
Loose or Intermittent Connection 430 430
No Apparent Adverse Event 416 416
Calibration Problem 410 410
Circuit Failure 302 302
Insufficient Information 295 295
Output Problem 225 225
Device Sensing Problem 185 185
Physical Resistance/Sticking 126 126
Failure to Read Input Signal 110 110
Display or Visual Feedback Problem 83 83
Display Difficult to Read 77 77
Missing Information 68 68
Incorrect Measurement 64 64
Application Program Freezes, Becomes Nonfunctional 62 62
Unable to Obtain Readings 60 60
Low Readings 50 50
Misassembled 50 50
High Readings 41 41
Failure to Power Up 39 39
Peeled/Delaminated 38 38
Pumping Stopped 37 37
Application Program Problem 29 29
Degraded 28 28
Naturally Worn 28 28
Failure to Cycle 25 25
Electrical /Electronic Property Problem 25 25
Power Problem 22 22
Temperature Problem 22 22
Gas Output Problem 21 21
Image Display Error/Artifact 19 19
Mechanical Problem 19 19
No Display/Image 17 17
Device Operates Differently Than Expected 16 16
Device Markings/Labelling Problem 15 15
Noise, Audible 14 14
Erratic or Intermittent Display 14 14
Unexpected Shutdown 13 13
Use of Device Problem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7133 7133
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 129 129
No Information 88 88
Unintended Extubation 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Cardiac Arrest 5 5
Low Oxygen Saturation 5 5
Unspecified Tissue Injury 4 4
Foreign Body In Patient 3 3
Hypoxia 3 3
Death 2 2
Respiratory Distress 2 2
Pain 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, Thermal 1 1
Injury 1 1
Chest Pain 1 1
Discomfort 1 1
Cardiopulmonary Arrest 1 1
Laceration(s) 1 1
Anxiety 1 1
Cough 1 1
Partial thickness (Second Degree) Burn 1 1
Pressure Sores 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Respiratory Insufficiency 1 1
Bruise/Contusion 1 1
Death, Intrauterine Fetal 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 Smiths Medical ASD Inc. II Jul-06-2018
8 Smiths Medical ASD, Inc. II Mar-20-2025
9 Southmedic, Inc. II Jul-24-2021
10 Southmedic, Inc. II Jan-25-2018
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