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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 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
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 2272
2022 2475 2475
2023 1638 1638
2024 1217 1217
2025 502 502

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3435 3435
Communication or Transmission Problem 2909 2909
Crack 2472 2472
Corroded 1027 1027
Failure to Calibrate 963 963
Appropriate Term/Code Not Available 945 945
Incorrect, Inadequate or Imprecise Result or Readings 741 741
Device Alarm System 686 686
Computer Software Problem 564 564
Contamination 530 530
Failure of Device to Self-Test 490 490
No Device Output 483 483
Loose or Intermittent Connection 439 439
Calibration Problem 423 423
No Apparent Adverse Event 416 416
Circuit Failure 304 304
Insufficient Information 295 295
Output Problem 227 227
Device Sensing Problem 185 185
Physical Resistance/Sticking 126 126
Missing Information 115 115
Failure to Read Input Signal 110 110
Display or Visual Feedback Problem 83 83
Display Difficult to Read 77 77
Incorrect Measurement 67 67
Unable to Obtain Readings 66 66
Application Program Freezes, Becomes Nonfunctional 62 62
Low Readings 52 52
Misassembled 50 50
High Readings 41 41
Failure to Power Up 39 39
Peeled/Delaminated 38 38
Pumping Stopped 37 37
Application Program Problem 30 30
Degraded 28 28
Naturally Worn 28 28
Failure to Cycle 25 25
Electrical /Electronic Property Problem 25 25
Power Problem 23 23
Gas Output Problem 22 22
Temperature Problem 22 22
Image Display Error/Artifact 20 20
Mechanical Problem 19 19
No Display/Image 17 17
Device Operates Differently Than Expected 16 16
Device Markings/Labelling Problem 15 15
Noise, Audible 14 14
Unexpected Shutdown 14 14
Erratic or Intermittent Display 14 14
Device Displays Incorrect Message 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7371 7371
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 132 132
No Information 88 88
Unintended Extubation 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Low Oxygen Saturation 5 5
Cardiac Arrest 5 5
Unspecified Tissue Injury 4 4
Hypoxia 3 3
Foreign Body In Patient 3 3
Respiratory Failure 2 2
Death 2 2
Pain 2 2
Respiratory Distress 2 2
Pressure Sores 1 1
Anxiety 1 1
Discomfort 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Burn, Thermal 1 1
Bruise/Contusion 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1
Death, Intrauterine Fetal 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoventilation 1 1
Lethargy 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Laceration(s) 1 1
Perforation 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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