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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
  1.  K192446  CO2 Mainstream Module
  2.  K192488  CO2 Sidestream Module
BLUEPOINT MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
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
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 3
PNEUMA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHMEDIC INC.
  SUBSTANTIALLY EQUIVALENT 1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1637 1637
2024 386 386

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3196 3196
Communication or Transmission Problem 2222 2222
Crack 2177 2177
Appropriate Term/Code Not Available 944 944
Corroded 891 891
Failure to Calibrate 809 809
Incorrect, Inadequate or Imprecise Result or Readings 710 710
Computer Software Problem 564 564
Device Alarm System 551 551
Contamination 507 507
Failure of Device to Self-Test 467 467
No Device Output 456 456
No Apparent Adverse Event 409 409
Loose or Intermittent Connection 394 394
Calibration Problem 341 341
Circuit Failure 298 298
Insufficient Information 294 294
Output Problem 204 204
Device Sensing Problem 176 176
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 107 107
Display Difficult to Read 76 76
Display or Visual Feedback Problem 71 71
Application Program Freezes, Becomes Nonfunctional 61 61
Misassembled 48 48
Unable to Obtain Readings 46 46
Pumping Stopped 37 37
Peeled/Delaminated 37 37
Failure to Power Up 37 37
Incorrect Measurement 34 34
High Readings 30 30
Low Readings 30 30
Degraded 27 27
Naturally Worn 27 27
Application Program Problem 26 26
Failure to Cycle 25 25
Electrical /Electronic Property Problem 23 23
Power Problem 22 22
Gas Output Problem 18 18
Image Display Error/Artifact 17 17
Temperature Problem 17 17
Mechanical Problem 15 15
Device Markings/Labelling Problem 15 15
No Display/Image 14 14
Erratic or Intermittent Display 13 13
False Alarm 12 12
Noise, Audible 11 11
Defective Device 10 10
Unexpected Shutdown 10 10
Defective Alarm 9 9
Use of Device Problem 9 9
Obstruction of Flow 8 8
Device Displays Incorrect Message 8 8
Defective Component 8 8
Device Ingredient or Reagent Problem 8 8
Mechanics Altered 8 8
Battery Problem 7 7
Application Program Version or Upgrade Problem 7 7
Component Missing 7 7
Material Split, Cut or Torn 6 6
Device Damaged Prior to Use 6 6
Material Deformation 6 6
Inaccurate Information 5 5
Failure to Align 5 5
Failure to Sense 5 5
Data Problem 5 5
Charging Problem 5 5
Suction Failure 5 5
Material Integrity Problem 4 4
Infusion or Flow Problem 4 4
Deformation Due to Compressive Stress 4 4
Electrical Power Problem 4 4
Component Misassembled 4 4
Inaccurate Delivery 4 4
Filtration Problem 4 4
No Audible Prompt/Feedback 4 4
Protective Measures Problem 4 4
Sensing Intermittently 4 4
Partial Blockage 3 3
Pressure Problem 3 3
Computer Operating System Problem 3 3
Material Fragmentation 3 3
Unclear Information 3 3
Intermittent Loss of Power 3 3
Moisture or Humidity Problem 3 3
Failure to Analyze Signal 3 3
Complete Loss of Power 3 3
Nonstandard Device 3 3
Detachment of Device or Device Component 3 3
Intermittent Communication Failure 3 3
Adverse Event Without Identified Device or Use Problem 3 3
No Audible Alarm 3 3
Unintended Application Program Shut Down 3 3
Gas/Air Leak 3 3
Sparking 3 3
Missing Information 3 3
Improper or Incorrect Procedure or Method 2 2
Inaccurate Flow Rate 2 2
Fracture 2 2
Failure to Charge 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6064 6064
No Patient Involvement 2984 2984
No Consequences Or Impact To Patient 117 117
Insufficient Information 108 108
No Information 81 81
No Known Impact Or Consequence To Patient 76 76
Unintended Extubation 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Cardiac Arrest 3 3
Death 2 2
Foreign Body In Patient 2 2
Unspecified Tissue Injury 2 2
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Anxiety 1 1
Discomfort 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Lethargy 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Laceration(s) 1 1
Pain 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 Southmedic, Inc. II Jul-24-2021
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