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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
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
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 1637 1637
2024 212 212

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3143 3143
Communication or Transmission Problem 2134 2134
Crack 2131 2131
Appropriate Term/Code Not Available 943 943
Corroded 875 875
Failure to Calibrate 784 784
Incorrect, Inadequate or Imprecise Result or Readings 700 700
Computer Software Problem 564 564
Device Alarm System 539 539
Contamination 498 498
Failure of Device to Self-Test 465 465
No Device Output 451 451
No Apparent Adverse Event 406 406
Loose or Intermittent Connection 372 372
Calibration Problem 336 336
Circuit Failure 295 295
Insufficient Information 292 292
Output Problem 201 201
Device Sensing Problem 176 176
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 105 105
Display Difficult to Read 74 74
Display or Visual Feedback Problem 70 70
Application Program Freezes, Becomes Nonfunctional 61 61
Misassembled 48 48
Unable to Obtain Readings 41 41
Pumping Stopped 37 37
Failure to Power Up 37 37
Peeled/Delaminated 36 36
Incorrect Measurement 34 34
Low Readings 29 29
High Readings 28 28
Degraded 27 27
Naturally Worn 27 27
Application Program Problem 26 26
Failure to Cycle 25 25
Power Problem 22 22
Electrical /Electronic Property Problem 22 22
Gas Output Problem 18 18
Image Display Error/Artifact 17 17
Temperature Problem 17 17
Mechanical Problem 15 15
Erratic or Intermittent Display 13 13
Device Markings/Labelling Problem 12 12
No Display/Image 12 12
False Alarm 12 12
Noise, Audible 10 10
Defective Device 9 9
Defective Alarm 9 9
Use of Device Problem 9 9
Obstruction of Flow 8 8
Device Displays Incorrect Message 8 8
Device Ingredient or Reagent Problem 8 8
Mechanics Altered 8 8
Unexpected Shutdown 8 8
Battery Problem 7 7
Application Program Version or Upgrade Problem 7 7
Component Missing 7 7
Material Split, Cut or Torn 6 6
Material Deformation 6 6
Device Damaged Prior to Use 6 6
Failure to Align 5 5
Inaccurate Information 5 5
Failure to Sense 5 5
Data Problem 5 5
Defective Component 5 5
Charging Problem 5 5
Suction Failure 5 5
Material Integrity Problem 4 4
Infusion or Flow Problem 4 4
Deformation Due to Compressive Stress 4 4
Electrical Power Problem 4 4
Component Misassembled 4 4
Protective Measures Problem 4 4
Sensing Intermittently 4 4
Inaccurate Delivery 4 4
Filtration Problem 4 4
No Audible Prompt/Feedback 4 4
Moisture or Humidity Problem 3 3
Failure to Analyze Signal 3 3
Nonstandard Device 3 3
Detachment of Device or Device Component 3 3
Partial Blockage 3 3
Pressure Problem 3 3
Computer Operating System Problem 3 3
Material Fragmentation 3 3
Unclear Information 3 3
Intermittent Loss of Power 3 3
Intermittent Communication Failure 3 3
Adverse Event Without Identified Device or Use Problem 3 3
No Audible Alarm 3 3
Unintended Application Program Shut Down 3 3
Gas/Air Leak 3 3
Sparking 3 3
Missing Information 3 3
Improper or Incorrect Procedure or Method 2 2
Inaccurate Flow Rate 2 2
Fracture 2 2
Failure to Charge 2 2
Therapeutic or Diagnostic Output Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5896 5896
No Patient Involvement 2984 2984
No Consequences Or Impact To Patient 117 117
Insufficient Information 103 103
No Information 81 81
No Known Impact Or Consequence To Patient 76 76
Unintended Extubation 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Cardiac Arrest 3 3
Death 2 2
Foreign Body In Patient 2 2
Unspecified Tissue Injury 2 2
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Anxiety 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Lethargy 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Laceration(s) 1 1
Pain 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 Southmedic, Inc. II Jul-24-2021
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