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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
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
ENGINEERED MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 3
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201590  EMMA Capnograph
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 2159 2159

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1950 1950
Communication or Transmission Problem 1466 1466
Crack 1418 1418
Appropriate Term/Code Not Available 940 940
Failure to Calibrate 638 638
Corroded 628 628
Incorrect, Inadequate or Imprecise Result or Readings 531 531
Contamination 486 486
Failure of Device to Self-Test 450 450
Device Alarm System 440 440
No Device Output 385 385
No Apparent Adverse Event 376 376
Computer Software Problem 339 339
Insufficient Information 268 268
Circuit Failure 261 261
Calibration Problem 213 213
Loose or Intermittent Connection 209 209
Output Problem 198 198
Device Sensing Problem 183 183
Failure to Read Input Signal 104 104
Display or Visual Feedback Problem 70 70
Application Program Freezes, Becomes Nonfunctional 56 56
Physical Resistance/Sticking 54 54
Display Difficult to Read 49 49
Misassembled 49 49
Unable to Obtain Readings 42 42
Incorrect Measurement 36 36
Pumping Stopped 36 36
Failure to Power Up 34 34
Peeled/Delaminated 31 31
Failure to Cycle 25 25
Naturally Worn 25 25
Application Program Problem 25 25
Degraded 24 24
High Readings 23 23
Low Readings 22 22
Electrical /Electronic Property Problem 21 21
Power Problem 20 20
Gas Output Problem 18 18
Device Operates Differently Than Expected 16 16
Image Display Error/Artifact 15 15
Temperature Problem 14 14
Mechanical Problem 13 13
No Audible Alarm 12 12
Device Displays Incorrect Message 12 12
Device Markings/Labelling Problem 11 11
Erratic or Intermittent Display 11 11
False Alarm 10 10
Use of Device Problem 10 10
Defective Device 10 10
Device Stops Intermittently 10 10
Noise, Audible 10 10
Mechanics Altered 8 8
Failure to Deliver 7 7
Obstruction of Flow 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Failure to Sense 7 7
Defective Alarm 7 7
No Display/Image 7 7
Unexpected Shutdown 7 7
Smoking 6 6
Device Inoperable 6 6
Defective Component 6 6
Component Missing 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Device Operational Issue 5 5
Charging Problem 5 5
Device Damaged Prior to Use 5 5
Invalid Sensing 5 5
Device Issue 5 5
Partial Blockage 5 5
Inaccurate Information 5 5
Protective Measures Problem 4 4
Intermittent Loss of Power 4 4
Data Problem 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 4 4
Device Ingredient or Reagent Problem 4 4
Electrical Power Problem 4 4
Infusion or Flow Problem 4 4
Filtration Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Moisture or Humidity Problem 3 3
Pressure Problem 3 3
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Sparking 3 3
Computer Operating System Problem 3 3
No Audible Prompt/Feedback 3 3
Device Emits Odor 3 3
Overheating of Device 3 3
Failure to Analyze Signal 3 3
Disconnection 3 3
Material Fragmentation 3 3
Component Misassembled 3 3
Intermittent Communication Failure 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3758 3758
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 80 80
Low Oxygen Saturation 3 3
Death 2 2
Cardiac Arrest 2 2
Hypoxia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
Respiratory Distress 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
Unintended Extubation 1 1
Laceration(s) 1 1
Pain 1 1
Perforation 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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