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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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
  1.  K222511  Oxy2Pro
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 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3069 3069
Crack 2095 2095
Communication or Transmission Problem 2060 2060
Appropriate Term/Code Not Available 943 943
Corroded 851 851
Failure to Calibrate 772 772
Incorrect, Inadequate or Imprecise Result or Readings 709 709
Computer Software Problem 564 564
Device Alarm System 524 524
Contamination 494 494
Failure of Device to Self-Test 462 462
No Device Output 442 442
No Apparent Adverse Event 405 405
Loose or Intermittent Connection 363 363
Calibration Problem 338 338
Insufficient Information 293 293
Circuit Failure 287 287
Output Problem 216 216
Device Sensing Problem 184 184
Physical Resistance/Sticking 112 112
Failure to Read Input Signal 105 105
Display Difficult to Read 75 75
Display or Visual Feedback Problem 72 72
Application Program Freezes, Becomes Nonfunctional 61 61
Misassembled 49 49
Unable to Obtain Readings 47 47
Incorrect Measurement 39 39
Failure to Power Up 37 37
Pumping Stopped 37 37
Peeled/Delaminated 36 36
Naturally Worn 28 28
Low Readings 28 28
High Readings 27 27
Degraded 27 27
Application Program Problem 26 26
Failure to Cycle 25 25
Electrical /Electronic Property Problem 22 22
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 Displays Incorrect Message 13 13
Erratic or Intermittent Display 13 13
No Display/Image 13 13
False Alarm 12 12
No Audible Alarm 12 12
Device Markings/Labelling Problem 12 12
Use of Device Problem 11 11
Noise, Audible 11 11
Defective Device 10 10
Defective Alarm 10 10
Device Stops Intermittently 10 10
Failure to Sense 10 10
Obstruction of Flow 9 9
Unexpected Shutdown 9 9
Device Ingredient or Reagent Problem 8 8
Mechanics Altered 8 8
Component Missing 7 7
Failure to Deliver 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Defective Component 6 6
Smoking 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Device Inoperable 6 6
Material Split, Cut or Torn 6 6
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
Charging Problem 5 5
Device Damaged Prior to Use 5 5
Invalid Sensing 5 5
Device Issue 5 5
Failure to Align 5 5
Inaccurate Delivery 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
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
Data Problem 4 4
Unintended Application Program Shut Down 3 3
Intermittent Communication Failure 3 3
Missing Information 3 3
Device Emits Odor 3 3
Overheating of Device 3 3
Failure to Analyze Signal 3 3
Material Fragmentation 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5750 5750
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 101 101
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
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Partial thickness (Second Degree) Burn 1 1
Death, Intrauterine Fetal 1 1
Hypersensitivity/Allergic reaction 1 1
Burn, Thermal 1 1
Lethargy 1 1
Pressure Sores 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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