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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
  1.  K210019  Unimed CO2 Mainstream Module Model Capno-M, Unimed ...

MDR Year MDR Reports MDR Events
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1637 1637
2024 386 386

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3196 3196
Communication or Transmission Problem 2222 2222
Crack 2177 2177
Appropriate Term/Code Not Available 944 944
Corroded 891 891
Failure to Calibrate 809 809
Incorrect, Inadequate or Imprecise Result or Readings 710 710
Computer Software Problem 564 564
Device Alarm System 551 551
Contamination 507 507
Failure of Device to Self-Test 467 467
No Device Output 456 456
No Apparent Adverse Event 409 409
Loose or Intermittent Connection 394 394
Calibration Problem 341 341
Circuit Failure 298 298
Insufficient Information 294 294
Output Problem 204 204
Device Sensing Problem 176 176
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 107 107
Display Difficult to Read 76 76
Display or Visual Feedback Problem 71 71
Application Program Freezes, Becomes Nonfunctional 61 61
Misassembled 48 48
Unable to Obtain Readings 46 46
Pumping Stopped 37 37
Peeled/Delaminated 37 37
Failure to Power Up 37 37
Incorrect Measurement 34 34
High Readings 30 30
Low Readings 30 30
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
No Display/Image 14 14
Erratic or Intermittent Display 13 13
False Alarm 12 12
Noise, Audible 11 11
Unexpected Shutdown 10 10
Defective Device 10 10
Defective Alarm 9 9
Use of Device Problem 9 9
Defective Component 8 8
Device Displays Incorrect Message 8 8
Obstruction of Flow 8 8
Device Ingredient or Reagent Problem 8 8
Mechanics Altered 8 8
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Component Missing 7 7
Device Damaged Prior to Use 6 6
Material Deformation 6 6
Material Split, Cut or Torn 6 6
Suction Failure 5 5
Inaccurate Information 5 5
Data Problem 5 5
Charging Problem 5 5
Failure to Align 5 5
Failure to Sense 5 5
Inaccurate Delivery 4 4
Sensing Intermittently 4 4
No Audible Prompt/Feedback 4 4
Electrical Power Problem 4 4
Filtration Problem 4 4
Deformation Due to Compressive Stress 4 4
Protective Measures Problem 4 4
Component Misassembled 4 4
Material Integrity Problem 4 4
Infusion or Flow Problem 4 4
Moisture or Humidity Problem 3 3
Pressure 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
Detachment of Device or Device Component 3 3
Computer Operating System Problem 3 3
Gas/Air Leak 3 3
Sparking 3 3
Nonstandard Device 3 3
Failure to Analyze Signal 3 3
No Audible Alarm 3 3
Partial Blockage 3 3
Material Fragmentation 3 3
Unintended Application Program Shut Down 3 3
Intermittent Communication Failure 3 3
Excess Flow or Over-Infusion 2 2
Leak/Splash 2 2
Inaccurate Flow Rate 2 2
Fluid/Blood Leak 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6064 6064
No Patient Involvement 2984 2984
No Consequences Or Impact To Patient 117 117
Insufficient Information 108 108
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
Discomfort 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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