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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
COVIDIEN
  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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1352 1352
Break 1067 1067
Appropriate Term/Code Not Available 939 939
Communication or Transmission Problem 794 794
Failure to Calibrate 541 541
Contamination 467 467
Incorrect, Inadequate or Imprecise Resultor Readings 445 445
Failure of Device to Self-Test 433 433
No Apparent Adverse Event 357 357
No Device Output 344 344
Computer Software Problem 334 334
Device Alarm System 263 263
Circuit Failure 230 230
Corroded 227 227
Insufficient Information 199 199
Device Sensing Problem 182 182
Output Problem 180 180
Loose or Intermittent Connection 149 149
Calibration Problem 130 130
Failure to Read Input Signal 96 96
Display or Visual Feedback Problem 65 65
Application Program Freezes, Becomes Nonfunctional 51 51
Physical Resistance/Sticking 39 39
Misassembled 36 36
Pumping Stopped 36 36
Unable to Obtain Readings 34 34
Incorrect Measurement 29 29
Failure to Power Up 27 27
Display Difficult to Read 25 25
Failure to Cycle 25 25
Naturally Worn 23 23
Peeled/Delaminated 21 21
Degraded 20 20
Electrical /Electronic Property Problem 18 18
Power Problem 17 17
Device Operates Differently Than Expected 16 16
Gas Output Problem 16 16
Low Readings 15 15
High Readings 13 13
Device Displays Incorrect Message 12 12
Image Display Error/Artifact 11 11
No Audible Alarm 10 10
Device Stops Intermittently 10 10
Temperature Problem 10 10
Erratic or Intermittent Display 9 9
Use of Device Problem 8 8
Mechanics Altered 8 8
Application Program Problem 8 8
Application Program Version or Upgrade Problem 7 7
Failure to Deliver 7 7
Mechanical Problem 7 7
Device Inoperable 6 6
Material Deformation 6 6
Material Integrity Problem 5 5
Device Operational Issue 5 5
Device Issue 5 5
Charging Problem 5 5
Defective Device 5 5
Invalid Sensing 5 5
Component Missing 5 5
Failure to Sense 5 5
Smoking 5 5
Partial Blockage 5 5
False Alarm 4 4
Defective Alarm 4 4
No Display/Image 4 4
Sensing Intermittently 4 4
Deformation Due to Compressive Stress 4 4
Defective Component 4 4
Battery Problem 4 4
Detachment of Device or Device Component 4 4
Electrical Power Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Noise, Audible 4 4
Unexpected Shutdown 4 4
Intermittent Communication Failure 3 3
Data Problem 3 3
Intermittent Loss of Power 3 3
Protective Measures Problem 3 3
Moisture or Humidity Problem 3 3
Device Markings/Labelling Problem 3 3
Obstruction of Flow 3 3
Computer Operating System Problem 3 3
Filtration Problem 3 3
Gas Leak 3 3
Human-Device Interface Problem 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
Leak/Splash 2 2
Excess Flow or Over-Infusion 2 2
Fluid Leak 2 2
Application Program Problem: Dose Calculation Error 2 2
Nonstandard Device 2 2
Loss of Power 2 2
Self-Activation or Keying 2 2
Failure to Zero 2 2
Inappropriate or Unexpected Reset 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3003 3003
No Clinical Signs, Symptoms or Conditions 1592 1592
No Known Impact Or Consequence To Patient 147 147
No Consequences Or Impact To Patient 143 143
No Information 88 88
Insufficient Information 73 73
Low Oxygen Saturation 3 3
Death 2 2
Hypoxia 2 2
Foreign Body In Patient 2 2
Respiratory Distress 2 2
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 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
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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