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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
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
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
PNEUMA THERAPEUTICS, INC.
  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
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 1317 1317

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2846 2846
Crack 1935 1935
Communication or Transmission Problem 1874 1874
Appropriate Term/Code Not Available 943 943
Corroded 840 840
Failure to Calibrate 735 735
Incorrect, Inadequate or Imprecise Result or Readings 657 657
Computer Software Problem 517 517
Device Alarm System 492 492
Contamination 489 489
Failure of Device to Self-Test 459 459
No Device Output 426 426
No Apparent Adverse Event 399 399
Loose or Intermittent Connection 337 337
Calibration Problem 294 294
Insufficient Information 293 293
Circuit Failure 281 281
Output Problem 213 213
Device Sensing Problem 180 180
Failure to Read Input Signal 105 105
Physical Resistance/Sticking 105 105
Display Difficult to Read 75 75
Display or Visual Feedback Problem 71 71
Application Program Freezes, Becomes Nonfunctional 60 60
Misassembled 48 48
Unable to Obtain Readings 45 45
Incorrect Measurement 37 37
Pumping Stopped 36 36
Peeled/Delaminated 36 36
Failure to Power Up 36 36
Naturally Worn 28 28
Low Readings 28 28
Degraded 27 27
High Readings 26 26
Application Program Problem 26 26
Failure to Cycle 25 25
Power Problem 22 22
Electrical /Electronic Property Problem 21 21
Gas Output Problem 18 18
Temperature Problem 17 17
Image Display Error/Artifact 15 15
Mechanical Problem 12 12
Erratic or Intermittent Display 12 12
False Alarm 12 12
Device Markings/Labelling Problem 12 12
Device Displays Incorrect Message 10 10
Noise, Audible 10 10
No Display/Image 10 10
Use of Device Problem 10 10
Defective Alarm 9 9
Obstruction of Flow 9 9
Defective Device 9 9
Unexpected Shutdown 9 9
Device Ingredient or Reagent Problem 8 8
Failure to Sense 8 8
Mechanics Altered 8 8
Component Missing 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 5 5
Device Damaged Prior to Use 5 5
Failure to Deliver 5 5
Device Issue 5 5
Charging Problem 5 5
No Audible Alarm 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Protective Measures Problem 4 4
Intermittent Loss of Power 4 4
Component Misassembled 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
Invalid Sensing 4 4
Failure to Align 4 4
Infusion or Flow Problem 4 4
Electrical Power Problem 4 4
Filtration Problem 4 4
Data Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Pressure Problem 3 3
Gas/Air Leak 3 3
Device Operates Differently Than Expected 3 3
Device Operational Issue 3 3
Inappropriate or Unexpected Reset 3 3
Moisture or Humidity Problem 3 3
Sparking 3 3
Computer Operating System Problem 3 3
Device Emits Odor 3 3
Material Fragmentation 3 3
Failure to Analyze Signal 3 3
Smoking 3 3
Device Stops Intermittently 3 3
No Audible Prompt/Feedback 3 3
Partial Blockage 3 3
Disconnection 3 3
Material Split, Cut or Torn 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5382 5382
No Patient Involvement 2990 2990
No Consequences Or Impact To Patient 132 132
No Known Impact Or Consequence To Patient 114 114
Insufficient Information 88 88
No Information 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Unintended Extubation 5 5
Foreign Body In Patient 3 3
Cardiac Arrest 3 3
Death 2 2
Respiratory Distress 2 2
Unspecified Tissue Injury 2 2
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
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Pressure Sores 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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