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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
  1.  K220533  Endoscopy Oxygen Mask
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 289 289

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3165 3165
Communication or Transmission Problem 2180 2180
Crack 2149 2149
Appropriate Term/Code Not Available 943 943
Corroded 884 884
Failure to Calibrate 796 796
Incorrect, Inadequate or Imprecise Result or Readings 717 717
Computer Software Problem 564 564
Device Alarm System 548 548
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 346 346
Circuit Failure 298 298
Insufficient Information 293 293
Output Problem 218 218
Device Sensing Problem 184 184
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 49 49
Unable to Obtain Readings 48 48
Incorrect Measurement 41 41
Failure to Power Up 37 37
Peeled/Delaminated 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 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 14 14
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
Use of Device Problem 11 11
Device Stops Intermittently 10 10
Defective Device 10 10
Defective Alarm 10 10
Failure to Sense 10 10
Obstruction of Flow 9 9
Unexpected Shutdown 9 9
Defective Component 8 8
Mechanics Altered 8 8
Device Ingredient or Reagent Problem 8 8
Component Missing 7 7
Failure to Deliver 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 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
Inaccurate Delivery 4 4
No Audible Prompt/Feedback 4 4
Electrical Power Problem 4 4
Filtration Problem 4 4
Deformation Due to Compressive Stress 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
Pressure Problem 3 3
Unclear Information 3 3
Missing Information 3 3
Unintended Application Program Shut Down 3 3
Intermittent Communication Failure 3 3
Material Fragmentation 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5975 5975
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 103 103
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
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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