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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
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUEPOINT MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CMI HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 2
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
SALTER LABS
  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
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 88 88
2017 58 58
2018 63 63
2019 141 141
2020 2306 2306
2021 1440 1440

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1322 1322
Appropriate Term/Code Not Available 938 938
Break 827 827
Communication or Transmission Problem 533 533
Failure to Calibrate 524 524
Contamination 446 446
Failure of Device to Self-Test 433 433
Incorrect, Inadequate or Imprecise Resultor Readings 418 418
No Device Output 333 333
Computer Software Problem 333 333
No Apparent Adverse Event 326 326
Circuit Failure 215 215
Device Alarm System 201 201
Device Sensing Problem 182 182
Output Problem 165 165
Insufficient Information 159 159
Loose or Intermittent Connection 126 126
Calibration Problem 110 110
Failure to Read Input Signal 94 94
Corroded 83 83
Display or Visual Feedback Problem 56 56
Application Program Freezes, Becomes Nonfunctional 51 51
Device Operates Differently Than Expected 40 40
Pumping Stopped 36 36
Physical Resistance/Sticking 35 35
Unable to Obtain Readings 29 29
Device Inoperable 25 25
Naturally Worn 23 23
Failure to Cycle 22 22
Device Displays Incorrect Message 22 22
Misassembled 22 22
Display Difficult to Read 20 20
Degraded 19 19
Incorrect Measurement 19 19
Failure to Power Up 16 16
Gas Output Problem 16 16
Peeled/Delaminated 15 15
Electrical /Electronic Property Problem 15 15
Power Problem 12 12
Device Stops Intermittently 11 11
Erratic or Intermittent Display 10 10
No Audible Alarm 10 10
High Readings 9 9
Low Readings 9 9
Mechanics Altered 8 8
Image Display Error/Artifact 8 8
Use of Device Problem 8 8
Application Program Problem 8 8
Application Program Version or Upgrade Problem 7 7
Failure to Deliver 7 7
Temperature Problem 7 7
Mechanical Problem 7 7
Failure to Sense 6 6
Detachment of Device or Device Component 6 6
Noise, Audible 6 6
Material Integrity Problem 6 6
Material Deformation 5 5
Charging Problem 5 5
Invalid Sensing 5 5
False Alarm 5 5
Device Operational Issue 5 5
Component Missing 5 5
Incorrect Or Inadequate Test Results 5 5
Device Issue 5 5
Device Emits Odor 5 5
Smoking 5 5
Overheating of Device 5 5
No Display/Image 5 5
Deformation Due to Compressive Stress 4 4
Defective Device 4 4
Gas Leak 4 4
Thermal Decomposition of Device 4 4
Occlusion Within Device 4 4
Disconnection 4 4
Battery Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Moisture or Humidity Problem 3 3
Defective Component 3 3
Sensing Intermittently 3 3
Failure to Analyze Signal 3 3
Calibration Error 3 3
Defective Alarm 3 3
Human-Device Interface Problem 3 3
Filtration Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 3 3
Sparking 3 3
Computer Operating System Problem 3 3
Intermittent Loss of Power 3 3
Unexpected Shutdown 2 2
Obstruction of Flow 2 2
Out-Of-Box Failure 2 2
No Flow 2 2
Complete Blockage 2 2
Melted 2 2
Nonstandard Device 2 2
False Reading From Device Non-Compliance 2 2
Fluid Leak 2 2
Material Fragmentation 2 2
Loss of Power 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3012 3012
No Clinical Signs, Symptoms or Conditions 794 794
No Known Impact Or Consequence To Patient 203 203
No Consequences Or Impact To Patient 152 152
No Information 99 99
Insufficient Information 34 34
Low Oxygen Saturation 4 4
Patient Problem/Medical Problem 3 3
Hypoxia 3 3
Foreign Body In Patient 2 2
Death 2 2
Respiratory Distress 2 2
Vomiting 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Burn, Thermal 1 1
Death, Intrauterine Fetal 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Laceration(s) 1 1
Pain 1 1
No Code Available 1 1
Respiratory Arrest 1 1
Missed Dose 1 1
Pressure Sores 1 1
Extubate 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Cyanosis 1 1
Hypersensitivity/Allergic reaction 1 1
Perforation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Partial thickness (Second 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 Medtronic I May-12-2016
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
9 Ventlab LLC II Jun-01-2016
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