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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 1076 1076

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1175 1175
Appropriate Term/Code Not Available 900 900
Break 712 712
Failure to Calibrate 504 504
Failure of Device to Self-Test 433 433
Contamination 415 415
Incorrect, Inadequate or Imprecise Resultor Readings 409 409
Computer Software Problem 333 333
Communication or Transmission Problem 323 323
No Device Output 309 309
No Apparent Adverse Event 201 201
Circuit Failure 186 186
Device Sensing Problem 181 181
Device Alarm System 166 166
Output Problem 152 152
Insufficient Information 127 127
Loose or Intermittent Connection 110 110
Failure to Read Input Signal 92 92
Calibration Problem 90 90
Corroded 80 80
Display or Visual Feedback Problem 52 52
Application Program Freezes, Becomes Nonfunctional 49 49
Device Operates Differently Than Expected 40 40
Pumping Stopped 36 36
Physical Resistance/Sticking 35 35
Device Inoperable 25 25
Naturally Worn 23 23
Failure to Cycle 22 22
Misassembled 22 22
Unable to Obtain Readings 21 21
Device Displays Incorrect Message 21 21
Gas Output Problem 16 16
Incorrect Measurement 15 15
Display Difficult to Read 15 15
Failure to Power Up 13 13
Device Stops Intermittently 11 11
Power Problem 11 11
Electrical /Electronic Property Problem 10 10
No Audible Alarm 10 10
Use of Device Problem 8 8
Application Program Problem 8 8
Low Readings 8 8
Application Program Version or Upgrade Problem 7 7
Failure to Deliver 7 7
Mechanical Problem 7 7
Failure to Sense 6 6
Detachment of Device or Device Component 6 6
Noise, Audible 6 6
Temperature Problem 6 6
Material Integrity Problem 6 6
Peeled/Delaminated 6 6
Mechanics Altered 5 5
Material Deformation 5 5
Charging Problem 5 5
Invalid Sensing 5 5
Device Issue 5 5
Incorrect Or Inadequate Test Results 5 5
Device Emits Odor 5 5
Device Operational Issue 5 5
Smoking 5 5
Overheating of Device 5 5
No Display/Image 5 5
Component Missing 4 4
Deformation Due to Compressive Stress 4 4
Gas Leak 4 4
Disconnection 4 4
High Readings 4 4
Erratic or Intermittent Display 4 4
Image Display Error/Artifact 4 4
Occlusion Within Device 4 4
Thermal Decomposition of Device 4 4
Calibration Error 3 3
False Alarm 3 3
Moisture or Humidity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Defective Component 3 3
Battery Problem 3 3
Human-Device Interface Problem 3 3
Filtration Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Computer Operating System Problem 3 3
Defective Device 3 3
Sparking 3 3
Intermittent Loss of Power 3 3
Unexpected Shutdown 2 2
No Flow 2 2
Out-Of-Box Failure 2 2
Loss of Power 2 2
False Reading From Device Non-Compliance 2 2
Melted 2 2
Nonstandard Device 2 2
Fluid Leak 2 2
Material Fragmentation 2 2
Low Test Results 2 2
Improper or Incorrect Procedure or Method 2 2
Pressure Problem 2 2
Defective Alarm 2 2
Partial Blockage 2 2
Application Program Problem: Dose Calculation Error 2 2
Device Difficult to Program or Calibrate 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3012 3012
No Clinical Signs, Symptoms or Conditions 390 390
No Known Impact Or Consequence To Patient 203 203
No Consequences Or Impact To Patient 152 152
No Information 99 99
Insufficient Information 24 24
Low Oxygen Saturation 4 4
Patient Problem/Medical Problem 3 3
Hypoxia 3 3
Death 2 2
Respiratory Distress 2 2
Foreign Body In Patient 2 2
Chest Pain 1 1
No Code Available 1 1
Vomiting 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Burn, Thermal 1 1
Death, Intrauterine Fetal 1 1
Laceration(s) 1 1
Pain 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 Jan-25-2018
8 Ventlab LLC II Jun-01-2016
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