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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
  1.  K172904  IntelliVue Capnography Extension, IntelliVue Micro ...
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 2293
2022 2475 2475
2023 1637 1640
2024 1216 1216
2025 1154 1154

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3514 3514
Communication or Transmission Problem 3145 3145
Crack 2668 2668
Corroded 1095 1096
Failure to Calibrate 1044 1044
Appropriate Term/Code Not Available 946 966
Device Alarm System 759 759
Incorrect, Inadequate or Imprecise Result or Readings 747 747
Computer Software Problem 564 564
Contamination 537 537
No Device Output 501 501
Calibration Problem 499 500
Failure of Device to Self-Test 496 497
Loose or Intermittent Connection 447 447
No Apparent Adverse Event 424 424
Circuit Failure 308 308
Insufficient Information 295 295
Output Problem 257 257
Device Sensing Problem 185 185
Unable to Obtain Readings 141 141
Physical Resistance/Sticking 138 138
Missing Information 125 125
Failure to Read Input Signal 111 111
Display or Visual Feedback Problem 104 104
Display Difficult to Read 78 78
Incorrect Measurement 70 70
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 54 54
Misassembled 51 51
High Readings 46 46
Failure to Power Up 40 40
Gas Output Problem 40 40
Image Display Error/Artifact 39 39
Pumping Stopped 39 39
Peeled/Delaminated 38 38
Application Program Problem 32 32
Naturally Worn 28 28
Degraded 28 28
Electrical /Electronic Property Problem 26 26
Failure to Cycle 25 25
Inadequate or Insufficient Training 24 24
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
Device Operates Differently Than Expected 16 16
Erratic or Intermittent Display 15 15
No Audible Alarm 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8015 8037
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 135 137
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
Pain 2 2
Bruise/Contusion 1 1
Lethargy 1 1
Death, Intrauterine Fetal 1 1
Bacterial Infection 1 1
Respiratory Insufficiency 1 1
Extubate 1 1
Inadequate Pain Relief 1 1
Pressure Sores 1 1
Partial thickness (Second Degree) Burn 1 1
Cough 1 1
Anxiety 1 1
Laceration(s) 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
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 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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