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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
BARBARAS DEVELOPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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 AS
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
  1.  K210112  XChange Device, XChange System
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
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 2293
2022 2475 2475
2023 1637 1640
2024 1216 1216
2025 1274 1274

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3518 3518
Communication or Transmission Problem 3191 3191
Crack 2683 2683
Corroded 1097 1098
Failure to Calibrate 1048 1048
Appropriate Term/Code Not Available 946 966
Device Alarm System 773 773
Incorrect, Inadequate or Imprecise Result or Readings 750 750
Computer Software Problem 565 565
Contamination 537 537
Calibration Problem 523 524
No Device Output 508 508
Failure of Device to Self-Test 496 497
Loose or Intermittent Connection 454 454
No Apparent Adverse Event 424 424
Circuit Failure 312 312
Insufficient Information 295 295
Output Problem 266 266
Device Sensing Problem 185 185
Unable to Obtain Readings 145 145
Physical Resistance/Sticking 138 138
Missing Information 125 125
Failure to Read Input Signal 111 111
Display or Visual Feedback Problem 107 107
Display Difficult to Read 78 78
Incorrect Measurement 70 70
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 57 57
Misassembled 51 51
High Readings 47 47
Gas Output Problem 45 45
Image Display Error/Artifact 43 43
Failure to Power Up 40 40
Pumping Stopped 39 39
Peeled/Delaminated 38 38
Application Program Problem 32 32
Degraded 28 28
Naturally Worn 28 28
Inadequate or Insufficient Training 27 27
Electrical /Electronic Property Problem 26 26
Failure to Cycle 25 25
Power Problem 24 24
Temperature Problem 23 23
Mechanical Problem 22 22
No Display/Image 22 22
Noise, Audible 17 17
Device Markings/Labelling Problem 17 17
Unexpected Shutdown 17 17
Device Operates Differently Than Expected 16 16
Failure to Analyze Signal 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8133 8155
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 136 138
No Information 88 88
Unintended Extubation 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Low Oxygen Saturation 6 6
Cardiac Arrest 5 5
Unspecified Tissue Injury 4 4
Foreign Body In Patient 3 3
Hypoxia 3 3
Death 2 2
Respiratory Failure 2 2
Respiratory Distress 2 2
Laceration(s) 2 2
Pain 2 2
Lethargy 1 1
Death, Intrauterine Fetal 1 1
Bruise/Contusion 1 1
Respiratory Insufficiency 1 1
Extubate 1 1
Inadequate Pain Relief 1 1
Pressure Sores 1 1
Bacterial Infection 1 1
Partial thickness (Second Degree) Burn 1 1
Cough 1 1
Anxiety 1 1
Cardiopulmonary Arrest 1 1
Discomfort 1 1
Chest Pain 1 1
Injury 1 1
Burn, Thermal 1 1
Perforation 1 1
Respiratory Arrest 1 1
Hypoventilation 1 1
Hypersensitivity/Allergic reaction 1 1
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 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 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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