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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 1
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
  1.  K181467  Microstream Luer Adult-Pediatric Intubated Samplin ...
  2.  K181624  Microstream Advance Neonatal-Infant Nasal Filter L ...
  3.  K200594  Capnostream 35 Portable Respiratory Monitor
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
POM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPIRION, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY MEDICAL DEVICES, 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 2306 2306
2021 2272 2272
2022 1069 1069

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1461 1461
Crack 1375 1375
Communication or Transmission Problem 1041 1041
Appropriate Term/Code Not Available 939 939
Failure to Calibrate 583 583
Incorrect, Inadequate or Imprecise Resultor Readings 486 486
Contamination 483 483
Corroded 450 450
Failure of Device to Self-Test 447 447
No Apparent Adverse Event 367 367
No Device Output 364 364
Computer Software Problem 334 334
Device Alarm System 333 333
Circuit Failure 238 238
Insufficient Information 216 216
Output Problem 189 189
Device Sensing Problem 182 182
Loose or Intermittent Connection 176 176
Calibration Problem 149 149
Failure to Read Input Signal 100 100
Display or Visual Feedback Problem 66 66
Application Program Freezes, Becomes Nonfunctional 55 55
Misassembled 49 49
Physical Resistance/Sticking 39 39
Pumping Stopped 36 36
Unable to Obtain Readings 36 36
Display Difficult to Read 32 32
Incorrect Measurement 32 32
Peeled/Delaminated 30 30
Failure to Power Up 29 29
Failure to Cycle 25 25
Degraded 24 24
Naturally Worn 23 23
Application Program Problem 22 22
Low Readings 19 19
Electrical /Electronic Property Problem 18 18
High Readings 17 17
Power Problem 17 17
Device Operates Differently Than Expected 16 16
Gas Output Problem 16 16
Temperature Problem 12 12
Device Displays Incorrect Message 12 12
Image Display Error/Artifact 11 11
No Audible Alarm 11 11
Device Stops Intermittently 10 10
Device Markings/Labelling Problem 10 10
Use of Device Problem 9 9
Erratic or Intermittent Display 9 9
Mechanics Altered 8 8
Application Program Version or Upgrade Problem 7 7
Failure to Deliver 7 7
Mechanical Problem 7 7
False Alarm 7 7
Defective Alarm 6 6
Device Inoperable 6 6
Material Deformation 6 6
Material Integrity Problem 5 5
Device Operational Issue 5 5
Invalid Sensing 5 5
Component Missing 5 5
Device Issue 5 5
Defective Device 5 5
Charging Problem 5 5
Failure to Sense 5 5
Smoking 5 5
Partial Blockage 5 5
No Display/Image 5 5
Noise, Audible 5 5
Protective Measures Problem 4 4
Unexpected Shutdown 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 4 4
Battery Problem 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Electrical Power Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Moisture or Humidity Problem 3 3
Data Problem 3 3
Filtration Problem 3 3
Gas Leak 3 3
Human-Device Interface Problem 3 3
Obstruction of Flow 3 3
Sparking 3 3
Computer Operating System Problem 3 3
Device Emits Odor 3 3
Overheating of Device 3 3
Failure to Analyze Signal 3 3
Disconnection 3 3
Material Fragmentation 3 3
Intermittent Communication Failure 3 3
Inaccurate Information 3 3
Intermittent Loss of Power 3 3
Material Split, Cut or Torn 2 2
Key or Button Unresponsive/not Working 2 2
Fluid Leak 2 2
Excess Flow or Over-Infusion 2 2
Application Program Problem: Dose Calculation Error 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3003 3003
No Clinical Signs, Symptoms or Conditions 2665 2665
No Known Impact Or Consequence To Patient 147 147
No Consequences Or Impact To Patient 143 143
No Information 88 88
Insufficient Information 74 74
Low Oxygen Saturation 3 3
Death 2 2
Hypoxia 2 2
Respiratory Distress 2 2
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Laceration(s) 1 1
Pain 1 1
Perforation 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1
Death, Intrauterine Fetal 1 1
Hypersensitivity/Allergic reaction 1 1
Burn, Thermal 1 1
Lethargy 1 1
Pressure Sores 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 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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