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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
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
PNEUMA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210112  XChange Device, XChange System
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 2476 2476
2023 246 246

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2204 2204
Communication or Transmission Problem 1624 1624
Crack 1444 1444
Appropriate Term/Code Not Available 940 940
Corroded 717 717
Failure to Calibrate 687 687
Incorrect, Inadequate or Imprecise Result or Readings 579 579
Contamination 486 486
Device Alarm System 466 466
Failure of Device to Self-Test 453 453
No Device Output 395 395
No Apparent Adverse Event 386 386
Computer Software Problem 363 363
Insufficient Information 278 278
Circuit Failure 271 271
Calibration Problem 258 258
Loose or Intermittent Connection 222 222
Output Problem 207 207
Device Sensing Problem 183 183
Failure to Read Input Signal 104 104
Physical Resistance/Sticking 86 86
Display or Visual Feedback Problem 70 70
Display Difficult to Read 62 62
Application Program Freezes, Becomes Nonfunctional 57 57
Misassembled 49 49
Unable to Obtain Readings 45 45
Incorrect Measurement 38 38
Pumping Stopped 36 36
Failure to Power Up 35 35
Peeled/Delaminated 33 33
Degraded 27 27
Naturally Worn 26 26
Low Readings 26 26
High Readings 25 25
Application Program Problem 25 25
Failure to Cycle 25 25
Electrical /Electronic Property Problem 21 21
Power Problem 20 20
Gas Output Problem 18 18
Temperature Problem 16 16
Device Operates Differently Than Expected 16 16
Image Display Error/Artifact 15 15
Mechanical Problem 13 13
Device Displays Incorrect Message 13 13
False Alarm 12 12
No Audible Alarm 12 12
Erratic or Intermittent Display 11 11
Device Markings/Labelling Problem 11 11
Defective Device 10 10
Use of Device Problem 10 10
Device Stops Intermittently 10 10
Noise, Audible 10 10
No Display/Image 9 9
Failure to Sense 8 8
Mechanics Altered 8 8
Failure to Deliver 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Obstruction of Flow 7 7
Defective Alarm 7 7
Unexpected Shutdown 7 7
Device Inoperable 6 6
Defective Component 6 6
Component Missing 6 6
Smoking 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Device Operational Issue 5 5
Device Damaged Prior to Use 5 5
Device Issue 5 5
Invalid Sensing 5 5
Charging Problem 5 5
Partial Blockage 5 5
Inaccurate Information 5 5
Intermittent Communication Failure 4 4
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
Filtration Problem 4 4
Infusion or Flow Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Pressure Problem 3 3
Moisture or Humidity Problem 3 3
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Inappropriate or Unexpected Reset 3 3
Computer Operating System Problem 3 3
Sparking 3 3
No Audible Prompt/Feedback 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4328 4328
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 82 82
Low Oxygen Saturation 3 3
Cardiac Arrest 3 3
Hypoxia 2 2
Death 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
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
Laceration(s) 1 1
Pain 1 1
Perforation 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 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 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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