• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUEPOINT MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CMI HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K170820  Capnograph and Oximeter
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 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. A.S.
  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
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 2272
2022 2475 2475
2023 1638 1638
2024 1215 1215
2025 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3397 3397
Communication or Transmission Problem 2721 2721
Crack 2393 2393
Corroded 1004 1004
Appropriate Term/Code Not Available 944 944
Failure to Calibrate 924 924
Incorrect, Inadequate or Imprecise Result or Readings 734 734
Device Alarm System 642 642
Computer Software Problem 564 564
Contamination 529 529
Failure of Device to Self-Test 486 486
No Device Output 477 477
Loose or Intermittent Connection 423 423
No Apparent Adverse Event 416 416
Calibration Problem 388 388
Circuit Failure 301 301
Insufficient Information 295 295
Output Problem 219 219
Device Sensing Problem 181 181
Physical Resistance/Sticking 125 125
Failure to Read Input Signal 109 109
Display Difficult to Read 77 77
Display or Visual Feedback Problem 74 74
Application Program Freezes, Becomes Nonfunctional 62 62
Incorrect Measurement 61 61
Unable to Obtain Readings 57 57
Misassembled 49 49
Low Readings 48 48
Missing Information 42 42
High Readings 40 40
Failure to Power Up 39 39
Peeled/Delaminated 38 38
Pumping Stopped 37 37
Application Program Problem 28 28
Naturally Worn 28 28
Degraded 28 28
Failure to Cycle 25 25
Electrical /Electronic Property Problem 24 24
Power Problem 22 22
Temperature Problem 20 20
Gas Output Problem 20 20
Image Display Error/Artifact 19 19
Mechanical Problem 18 18
No Display/Image 17 17
Device Markings/Labelling Problem 15 15
Erratic or Intermittent Display 14 14
Unexpected Shutdown 13 13
Noise, Audible 13 13
False Alarm 12 12
Use of Device Problem 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6937 6937
No Patient Involvement 2990 2990
No Consequences Or Impact To Patient 132 132
Insufficient Information 129 129
No Known Impact Or Consequence To Patient 114 114
No Information 81 81
Unintended Extubation 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Cardiac Arrest 4 4
Unspecified Tissue Injury 4 4
Low Oxygen Saturation 3 3
Foreign Body In Patient 3 3
Pain 2 2
Death 2 2
Respiratory Distress 2 2
Hypoxia 2 2
Lethargy 1 1
Hypoventilation 1 1
Chest Pain 1 1
Patient Problem/Medical Problem 1 1
Pressure Sores 1 1
Cyanosis 1 1
Anxiety 1 1
Inadequate Pain Relief 1 1
Cardiopulmonary Arrest 1 1
Extubate 1 1
Injury 1 1
Respiratory Arrest 1 1
Cough 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Bruise/Contusion 1 1
Perforation 1 1
Respiratory Insufficiency 1 1
Discomfort 1 1
Superficial (First Degree) Burn 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 Oct-03-2018
6 Smiths Medical ASD Inc. II Jul-06-2018
7 Southmedic, Inc. II Jul-24-2021
8 Southmedic, Inc. II Jan-25-2018
-
-