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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
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
ENDURE INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213767  Endure ETCO2/02 Nasal Cannula
ENGINEERED MEDICAL SYSTEMS INC.
  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
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
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 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 3198 3198
Communication or Transmission Problem 2222 2222
Crack 2177 2177
Appropriate Term/Code Not Available 944 944
Corroded 891 891
Failure to Calibrate 810 810
Incorrect, Inadequate or Imprecise Result or Readings 726 726
Computer Software Problem 564 564
Device Alarm System 553 553
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 349 349
Circuit Failure 298 298
Insufficient Information 295 295
Output Problem 220 220
Device Sensing Problem 184 184
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 107 107
Display Difficult to Read 77 77
Display or Visual Feedback Problem 73 73
Application Program Freezes, Becomes Nonfunctional 61 61
Unable to Obtain Readings 53 53
Misassembled 49 49
Incorrect Measurement 41 41
Failure to Power Up 37 37
Peeled/Delaminated 37 37
Pumping Stopped 37 37
Low Readings 32 32
High 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 19 19
Temperature Problem 18 18
Image Display Error/Artifact 17 17
Device Operates Differently Than Expected 16 16
Device Markings/Labelling Problem 15 15
No Display/Image 15 15
Erratic or Intermittent Display 13 13
Device Displays Incorrect Message 13 13
False Alarm 12 12
No Audible Alarm 12 12
Noise, Audible 12 12
Unexpected Shutdown 11 11
Defective Device 11 11
Use of Device Problem 11 11
Device Stops Intermittently 10 10
Defective Alarm 10 10
Failure to Sense 10 10
Defective Component 9 9
Obstruction of Flow 9 9
Device Ingredient or Reagent Problem 8 8
Mechanics Altered 8 8
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Component Missing 7 7
Failure to Deliver 7 7
Device Damaged Prior to Use 6 6
Device Inoperable 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Smoking 6 6
Material Split, Cut or Torn 6 6
Data Problem 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Partial Blockage 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Operational Issue 5 5
Device Issue 5 5
Invalid Sensing 5 5
Charging Problem 5 5
Failure to Align 5 5
Deformation Due to Compressive Stress 4 4
Inaccurate Delivery 4 4
No Audible Prompt/Feedback 4 4
Electrical Power Problem 4 4
Filtration Problem 4 4
Detachment of Device or Device Component 4 4
Infusion or Flow Problem 4 4
Disconnection 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Intermittent Loss of Power 4 4
Protective Measures Problem 4 4
Component Misassembled 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
Material Fragmentation 3 3
Overheating of Device 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6066 6066
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 108 108
No Information 88 88
Unintended Extubation 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 3 3
Low Oxygen Saturation 3 3
Cardiac Arrest 3 3
Hypoxia 2 2
Death 2 2
Respiratory Distress 2 2
Unspecified Tissue Injury 2 2
Partial thickness (Second Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Death, Intrauterine Fetal 1 1
Hypersensitivity/Allergic reaction 1 1
Burn, Thermal 1 1
Lethargy 1 1
Pressure Sores 1 1
Anxiety 1 1
Discomfort 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Laceration(s) 1 1
Pain 1 1
Perforation 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 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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