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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
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
  1.  K210112  XChange Device, XChange System
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 1638 1638
2024 827 827

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3302 3302
Communication or Transmission Problem 2461 2461
Crack 2292 2292
Appropriate Term/Code Not Available 944 944
Corroded 938 938
Failure to Calibrate 862 862
Incorrect, Inadequate or Imprecise Result or Readings 720 720
Device Alarm System 604 604
Computer Software Problem 564 564
Contamination 517 517
Failure of Device to Self-Test 474 474
No Device Output 464 464
No Apparent Adverse Event 411 411
Loose or Intermittent Connection 405 405
Calibration Problem 357 357
Circuit Failure 300 300
Insufficient Information 294 294
Output Problem 204 204
Device Sensing Problem 176 176
Physical Resistance/Sticking 116 116
Failure to Read Input Signal 109 109
Display Difficult to Read 76 76
Display or Visual Feedback Problem 72 72
Application Program Freezes, Becomes Nonfunctional 62 62
Unable to Obtain Readings 50 50
Misassembled 48 48
Incorrect Measurement 37 37
Failure to Power Up 37 37
Peeled/Delaminated 37 37
Pumping Stopped 37 37
High Readings 33 33
Low Readings 31 31
Missing Information 29 29
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 19 19
Image Display Error/Artifact 18 18
Temperature Problem 17 17
Device Markings/Labelling Problem 15 15
Mechanical Problem 15 15
No Display/Image 15 15
Erratic or Intermittent Display 14 14
Noise, Audible 12 12
False Alarm 12 12
Unexpected Shutdown 12 12
Defective Device 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6496 6496
No Patient Involvement 2984 2984
No Consequences Or Impact To Patient 117 117
Insufficient Information 114 114
No Information 81 81
No Known Impact Or Consequence To Patient 76 76
Unintended Extubation 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Tissue Injury 4 4
Cardiac Arrest 3 3
Death 2 2
Foreign Body In Patient 2 2
Hypoxia 2 2
Cyanosis 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoventilation 1 1
Respiratory Arrest 1 1
Chest Pain 1 1
Discomfort 1 1
Cardiopulmonary Arrest 1 1
Laceration(s) 1 1
Pain 1 1
Anxiety 1 1
Cough 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Respiratory Insufficiency 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 Southmedic, Inc. II Jul-24-2021
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