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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 289 289

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3163 3163
Communication or Transmission Problem 2180 2180
Crack 2149 2149
Appropriate Term/Code Not Available 943 943
Corroded 884 884
Failure to Calibrate 795 795
Incorrect, Inadequate or Imprecise Result or Readings 701 701
Computer Software Problem 564 564
Device Alarm System 546 546
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 338 338
Circuit Failure 298 298
Insufficient Information 292 292
Output Problem 202 202
Device Sensing Problem 176 176
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 105 105
Display Difficult to Read 75 75
Display or Visual Feedback Problem 71 71
Application Program Freezes, Becomes Nonfunctional 61 61
Misassembled 48 48
Unable to Obtain Readings 41 41
Failure to Power Up 37 37
Pumping Stopped 37 37
Peeled/Delaminated 37 37
Incorrect Measurement 34 34
High Readings 30 30
Low Readings 29 29
Naturally Worn 27 27
Degraded 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 18 18
Image Display Error/Artifact 17 17
Temperature Problem 17 17
Device Markings/Labelling Problem 15 15
Mechanical Problem 15 15
Erratic or Intermittent Display 13 13
No Display/Image 13 13
False Alarm 12 12
Noise, Audible 11 11
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
Unexpected Shutdown 8 8
Mechanics Altered 8 8
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Defective Component 7 7
Component Missing 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
Charging Problem 5 5
Failure to Align 5 5
Failure to Sense 5 5
Sensing Intermittently 4 4
No Audible Prompt/Feedback 4 4
Inaccurate Delivery 4 4
Deformation Due to Compressive Stress 4 4
Electrical Power Problem 4 4
Infusion or Flow Problem 4 4
Filtration Problem 4 4
Component Misassembled 4 4
Material Integrity Problem 4 4
Protective Measures Problem 4 4
Pressure Problem 3 3
Moisture or Humidity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Unclear Information 3 3
Missing Information 3 3
Complete Loss of Power 3 3
Intermittent Loss of Power 3 3
Gas/Air Leak 3 3
Detachment of Device or Device Component 3 3
Computer Operating System Problem 3 3
Sparking 3 3
Nonstandard Device 3 3
Material Fragmentation 3 3
Failure to Analyze Signal 3 3
No Audible Alarm 3 3
Partial Blockage 3 3
Unintended Application Program Shut Down 3 3
Intermittent Communication Failure 3 3
Complete Blockage 2 2
Thermal Decomposition of Device 2 2
Failure to Charge 2 2
Disconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5973 5973
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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