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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 3
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
ENDURE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXOSTAT MEDICAL, 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
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
  1.  K173147  SuperNO2VA Et Device
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
2026 406 406

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3536 3536
Communication or Transmission Problem 3306 3306
Crack 2694 2694
Corroded 1106 1107
Failure to Calibrate 1099 1099
Appropriate Term/Code Not Available 946 966
Device Alarm System 842 842
Incorrect, Inadequate or Imprecise Result or Readings 767 767
Calibration Problem 614 615
Computer Software Problem 566 566
Contamination 538 538
No Device Output 533 533
Failure of Device to Self-Test 504 505
Loose or Intermittent Connection 464 464
No Apparent Adverse Event 428 428
Circuit Failure 314 314
Insufficient Information 297 297
Output Problem 282 282
Device Sensing Problem 185 185
Unable to Obtain Readings 150 150
Physical Resistance/Sticking 139 139
Missing Information 125 125
Display or Visual Feedback Problem 117 117
Failure to Read Input Signal 111 111
Display Difficult to Read 78 78
Incorrect Measurement 74 74
Inadequate or Insufficient Training 65 65
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 62 62
High Readings 53 53
Image Display Error/Artifact 52 52
Gas Output Problem 51 51
Misassembled 51 51
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 27 27
Failure to Cycle 25 25
Power Problem 24 24
No Display/Image 23 23
Mechanical Problem 23 23
Temperature Problem 23 23
Use of Device Problem 18 19
Noise, Audible 18 18
Unexpected Shutdown 17 17
Failure to Analyze Signal 17 17
Device Markings/Labelling Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8533 8555
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 139 141
No Information 88 88
Unintended Extubation 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Low Oxygen Saturation 8 8
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
Eye Injury 1 1
Cardiopulmonary Arrest 1 1
Discomfort 1 1
Chest Pain 1 1
Injury 1 1
Burn(s) 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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