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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
  1.  K213518  CARESCAPE CO2 Microstream parameter
  2.  K213911  Microstream CO2 NanoPod
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K213518  CARESCAPE CO2 Microstream parameter
  2.  K213911  Microstream CO2 NanoPod
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 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 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3521 3521
Communication or Transmission Problem 3217 3217
Crack 2690 2690
Corroded 1105 1106
Failure to Calibrate 1055 1055
Appropriate Term/Code Not Available 946 966
Device Alarm System 785 785
Incorrect, Inadequate or Imprecise Result or Readings 747 747
Computer Software Problem 565 565
Calibration Problem 551 552
Contamination 537 537
No Device Output 512 512
Failure of Device to Self-Test 497 498
Loose or Intermittent Connection 455 455
No Apparent Adverse Event 424 424
Circuit Failure 313 313
Insufficient Information 295 295
Output Problem 268 268
Device Sensing Problem 181 181
Unable to Obtain Readings 144 144
Physical Resistance/Sticking 138 138
Missing Information 125 125
Failure to Read Input Signal 111 111
Display or Visual Feedback Problem 109 109
Display Difficult to Read 78 78
Incorrect Measurement 70 70
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 60 60
Misassembled 50 50
Inadequate or Insufficient Training 48 48
Gas Output Problem 48 48
High Readings 47 47
Image Display Error/Artifact 44 44
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
Electrical /Electronic Property Problem 26 26
Failure to Cycle 25 25
Power Problem 24 24
Temperature Problem 22 22
Mechanical Problem 22 22
No Display/Image 22 22
Noise, Audible 18 18
Failure to Analyze Signal 17 17
Unexpected Shutdown 17 17
Device Markings/Labelling Problem 17 17
Use of Device Problem 16 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8233 8255
No Patient Involvement 2990 2990
Insufficient Information 138 140
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, Conditions Term / Code Not Available 9 9
Cardiac Arrest 5 5
Unspecified Tissue Injury 4 4
Low Oxygen Saturation 4 4
Foreign Body In Patient 3 3
Death 2 2
Respiratory Distress 2 2
Pain 2 2
Laceration(s) 2 2
Hypoxia 2 2
Respiratory Failure 2 2
Cyanosis 1 1
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoventilation 1 1
Respiratory Arrest 1 1
Perforation 1 1
Injury 1 1
Chest Pain 1 1
Discomfort 1 1
Cardiopulmonary Arrest 1 1
Anxiety 1 1
Cough 1 1
Pressure Sores 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Respiratory Insufficiency 1 1
Bacterial Infection 1 1
Lethargy 1 1
Bruise/Contusion 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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