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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
  1.  K192446  CO2 Mainstream Module
  2.  K192488  CO2 Sidestream Module
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. A.S.
  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
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 2292
2022 2475 2475
2023 1637 1637
2024 1216 1216
2025 1057 1057

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3501 3501
Communication or Transmission Problem 3117 3117
Crack 2644 2644
Corroded 1092 1092
Failure to Calibrate 1024 1024
Appropriate Term/Code Not Available 946 966
Device Alarm System 750 750
Incorrect, Inadequate or Imprecise Result or Readings 747 747
Computer Software Problem 564 564
Contamination 537 537
No Device Output 500 500
Failure of Device to Self-Test 496 496
Calibration Problem 470 470
Loose or Intermittent Connection 444 444
No Apparent Adverse Event 422 422
Circuit Failure 308 308
Insufficient Information 295 295
Output Problem 252 252
Device Sensing Problem 185 185
Physical Resistance/Sticking 138 138
Unable to Obtain Readings 136 136
Missing Information 124 124
Failure to Read Input Signal 111 111
Display or Visual Feedback Problem 101 101
Display Difficult to Read 78 78
Incorrect Measurement 70 70
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 53 53
Misassembled 51 51
High Readings 43 43
Failure to Power Up 40 40
Pumping Stopped 39 39
Peeled/Delaminated 38 38
Gas Output Problem 37 37
Image Display Error/Artifact 35 35
Application Program Problem 32 32
Naturally Worn 28 28
Degraded 28 28
Failure to Cycle 25 25
Electrical /Electronic Property Problem 25 25
Power Problem 24 24
Temperature Problem 23 23
Mechanical Problem 22 22
No Display/Image 22 22
Inadequate or Insufficient Training 18 18
Noise, Audible 17 17
Device Operates Differently Than Expected 16 16
Device Markings/Labelling Problem 15 15
Erratic or Intermittent Display 15 15
Failure to Analyze Signal 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7921 7941
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 133 133
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 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 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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