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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
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
  1.  K180902  MediPines Gas Exchange Monitor (GEM), Accessory Mo ...
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 63 63
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1637 1637
2024 474 474

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3228 3228
Communication or Transmission Problem 2277 2277
Crack 2200 2200
Appropriate Term/Code Not Available 944 944
Corroded 904 904
Failure to Calibrate 822 822
Incorrect, Inadequate or Imprecise Result or Readings 730 730
Computer Software Problem 564 564
Device Alarm System 554 554
Contamination 509 509
Failure of Device to Self-Test 469 469
No Device Output 457 457
No Apparent Adverse Event 409 409
Loose or Intermittent Connection 396 396
Calibration Problem 346 346
Circuit Failure 298 298
Insufficient Information 295 295
Output Problem 218 218
Device Sensing Problem 180 180
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 48 48
Incorrect Measurement 40 40
Peeled/Delaminated 37 37
Failure to Power Up 37 37
Pumping Stopped 37 37
High Readings 32 32
Low Readings 32 32
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 18 18
Image Display Error/Artifact 17 17
Temperature Problem 17 17
No Display/Image 15 15
Device Markings/Labelling Problem 15 15
Erratic or Intermittent Display 13 13
False Alarm 12 12
Noise, Audible 12 12
Unexpected Shutdown 12 12
Use of Device Problem 11 11
Defective Device 10 10
Device Displays Incorrect Message 10 10
Device Ingredient or Reagent Problem 10 10
Obstruction of Flow 9 9
Defective Component 9 9
Defective Alarm 9 9
Failure to Sense 9 9
Mechanics Altered 8 8
Component Missing 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Device Damaged Prior to Use 6 6
Material Deformation 6 6
Material Split, Cut or Torn 6 6
Data Problem 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Material Integrity Problem 5 5
Charging Problem 5 5
Device Issue 5 5
Failure to Deliver 5 5
Failure to Align 5 5
No Audible Alarm 5 5
Sensing Intermittently 4 4
Nonstandard Device 4 4
Inaccurate Delivery 4 4
Invalid Sensing 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
Protective Measures Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Intermittent Loss of Power 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
Inappropriate or Unexpected Reset 3 3
Pressure Problem 3 3
Moisture or Humidity Problem 3 3
Gas/Air Leak 3 3
Device Operates Differently Than Expected 3 3
Device Operational Issue 3 3
Computer Operating System Problem 3 3
Sparking 3 3
Device Emits Odor 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6149 6149
No Patient Involvement 2990 2990
No Consequences Or Impact To Patient 132 132
No Known Impact Or Consequence To Patient 114 114
Insufficient Information 109 109
No Information 81 81
Unintended Extubation 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Tissue Injury 4 4
Foreign Body In Patient 3 3
Cardiac Arrest 3 3
Death 2 2
Respiratory Distress 2 2
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Laceration(s) 1 1
Pain 1 1
Perforation 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1
Pressure Sores 1 1
Anxiety 1 1
Discomfort 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 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 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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