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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device analyzer, gas, carbon-dioxide, gaseous-phase
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
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 3
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 2
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
POM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPIRION, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY MEDICAL DEVICES, 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 1

MDR Year MDR Reports MDR Events
2017 58 58
2018 63 63
2019 141 141
2020 2306 2306
2021 2272 2272
2022 1750 1750

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1751 1751
Crack 1404 1404
Communication or Transmission Problem 1316 1316
Appropriate Term/Code Not Available 940 940
Failure to Calibrate 621 621
Corroded 560 560
Incorrect, Inadequate or Imprecise Resultor Readings 510 510
Contamination 485 485
Failure of Device to Self-Test 449 449
Device Alarm System 404 404
No Device Output 380 380
No Apparent Adverse Event 373 373
Computer Software Problem 337 337
Insufficient Information 265 265
Circuit Failure 255 255
Calibration Problem 207 207
Loose or Intermittent Connection 200 200
Output Problem 195 195
Device Sensing Problem 182 182
Failure to Read Input Signal 102 102
Display or Visual Feedback Problem 69 69
Application Program Freezes, Becomes Nonfunctional 56 56
Misassembled 49 49
Physical Resistance/Sticking 46 46
Unable to Obtain Readings 41 41
Display Difficult to Read 38 38
Pumping Stopped 36 36
Incorrect Measurement 35 35
Failure to Power Up 32 32
Peeled/Delaminated 31 31
Failure to Cycle 25 25
Application Program Problem 25 25
Degraded 24 24
Naturally Worn 23 23
High Readings 20 20
Electrical /Electronic Property Problem 20 20
Low Readings 19 19
Power Problem 18 18
Gas Output Problem 17 17
Device Operates Differently Than Expected 16 16
Image Display Error/Artifact 15 15
Temperature Problem 14 14
Device Displays Incorrect Message 12 12
No Audible Alarm 12 12
Mechanical Problem 11 11
Device Markings/Labelling Problem 11 11
Device Stops Intermittently 10 10
Use of Device Problem 10 10
False Alarm 9 9
Erratic or Intermittent Display 9 9
Noise, Audible 8 8
Mechanics Altered 8 8
Application Program Version or Upgrade Problem 7 7
Defective Device 7 7
Failure to Deliver 7 7
Defective Alarm 7 7
Failure to Sense 7 7
Unexpected Shutdown 7 7
Smoking 6 6
Device Inoperable 6 6
Component Missing 6 6
Material Deformation 6 6
Material Integrity Problem 5 5
Device Operational Issue 5 5
Device Issue 5 5
Device Damaged Prior to Use 5 5
Defective Component 5 5
Invalid Sensing 5 5
Battery Problem 5 5
Charging Problem 5 5
Partial Blockage 5 5
No Display/Image 5 5
Sensing Intermittently 4 4
Nonstandard Device 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 4 4
Obstruction of Flow 4 4
Electrical Power Problem 4 4
Data Problem 4 4
Protective Measures Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Inaccurate Information 4 4
Intermittent Communication Failure 3 3
Intermittent Loss of Power 3 3
Filtration Problem 3 3
Gas Leak 3 3
Human-Device Interface Problem 3 3
Infusion or Flow Problem 3 3
Moisture or Humidity Problem 3 3
Computer Operating System Problem 3 3
Sparking 3 3
Overheating of Device 3 3
Device Emits Odor 3 3
Failure to Analyze Signal 3 3
Disconnection 3 3
Material Fragmentation 3 3
Leak/Splash 2 2
Inaccurate Flow Rate 2 2
Fluid Leak 2 2
Excess Flow or Over-Infusion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3350 3350
No Patient Involvement 3003 3003
No Known Impact Or Consequence To Patient 147 147
No Consequences Or Impact To Patient 143 143
No Information 88 88
Insufficient Information 78 78
Low Oxygen Saturation 3 3
Death 2 2
Hypoxia 2 2
Respiratory Distress 2 2
Unspecified Tissue Injury 2 2
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Partial thickness (Second Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Laceration(s) 1 1
Pain 1 1
Perforation 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1
Death, Intrauterine Fetal 1 1
Hypersensitivity/Allergic reaction 1 1
Burn, Thermal 1 1
Lethargy 1 1
Pressure Sores 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 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 Oridion Medical 1987 Ltd. II Oct-03-2018
5 Smiths Medical ASD Inc. II Jul-06-2018
6 Southmedic, Inc. II Jul-24-2021
7 Southmedic, Inc. II Jan-25-2018
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