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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
  1.  K203762  Nellcor EASYCAP II Adult Colorimetric CO2 Detector ...
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
ENDURE INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL SYSTEMS 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
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 3
PNEUMA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPIRION, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHMEDIC INC.
  SUBSTANTIALLY EQUIVALENT 1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 63 63
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1637 1637
2024 289 289

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3164 3164
Communication or Transmission Problem 2180 2180
Crack 2149 2149
Appropriate Term/Code Not Available 943 943
Corroded 884 884
Failure to Calibrate 795 795
Incorrect, Inadequate or Imprecise Result or Readings 713 713
Computer Software Problem 564 564
Device Alarm System 546 546
Contamination 505 505
Failure of Device to Self-Test 466 466
No Device Output 452 452
No Apparent Adverse Event 408 408
Loose or Intermittent Connection 382 382
Calibration Problem 342 342
Circuit Failure 298 298
Insufficient Information 293 293
Output Problem 216 216
Device Sensing Problem 180 180
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 105 105
Display Difficult to Read 76 76
Display or Visual Feedback Problem 73 73
Application Program Freezes, Becomes Nonfunctional 61 61
Misassembled 48 48
Unable to Obtain Readings 46 46
Incorrect Measurement 40 40
Peeled/Delaminated 37 37
Failure to Power Up 37 37
Pumping Stopped 37 37
High Readings 31 31
Low Readings 31 31
Naturally Worn 28 28
Degraded 27 27
Application Program Problem 26 26
Failure to Cycle 25 25
Electrical /Electronic Property Problem 24 24
Power Problem 22 22
Gas Output Problem 19 19
Mechanical Problem 18 18
Image Display Error/Artifact 17 17
Temperature Problem 17 17
Device Markings/Labelling Problem 15 15
No Display/Image 14 14
Erratic or Intermittent Display 13 13
False Alarm 12 12
Noise, Audible 12 12
Device Displays Incorrect Message 10 10
Use of Device Problem 10 10
Defective Device 9 9
Obstruction of Flow 9 9
Defective Alarm 9 9
Unexpected Shutdown 9 9
Failure to Sense 8 8
Defective Component 8 8
Device Ingredient or Reagent Problem 8 8
Mechanics Altered 8 8
Component Missing 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Device Damaged Prior to Use 6 6
Material Deformation 6 6
Material Split, Cut or Torn 6 6
Data Problem 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Material Integrity Problem 5 5
Charging Problem 5 5
Device Issue 5 5
Failure to Deliver 5 5
Failure to Align 5 5
No Audible Alarm 5 5
Sensing Intermittently 4 4
Nonstandard Device 4 4
Inaccurate Delivery 4 4
Invalid Sensing 4 4
No Audible Prompt/Feedback 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 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
Protective Measures Problem 4 4
Component Misassembled 4 4
Intermittent Loss of Power 4 4
Complete Loss of Power 3 3
Unintended Application Program Shut Down 3 3
Intermittent Communication Failure 3 3
Unclear Information 3 3
Missing Information 3 3
Pressure Problem 3 3
Moisture or Humidity Problem 3 3
Gas/Air Leak 3 3
Inappropriate or Unexpected Reset 3 3
Device Operates Differently Than Expected 3 3
Device Operational Issue 3 3
Sparking 3 3
Computer Operating System Problem 3 3
Device Emits Odor 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5973 5973
No Patient Involvement 2990 2990
No Consequences Or Impact To Patient 132 132
No Known Impact Or Consequence To Patient 114 114
Insufficient Information 103 103
No Information 81 81
Unintended Extubation 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 3 3
Cardiac Arrest 3 3
Death 2 2
Respiratory Distress 2 2
Unspecified Tissue Injury 2 2
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Laceration(s) 1 1
Pain 1 1
Perforation 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1
Pressure Sores 1 1
Anxiety 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Low Oxygen Saturation 1 1
Lethargy 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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