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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
  1.  K213518  CARESCAPE CO2 Microstream parameter
  2.  K213911  Microstream CO2 NanoPod
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K213518  CARESCAPE CO2 Microstream parameter
  2.  K213911  Microstream CO2 NanoPod
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 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
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
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
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 2302 2302
2021 2272 2272
2022 2475 2475
2023 1317 1317

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2847 2847
Crack 1935 1935
Communication or Transmission Problem 1874 1874
Appropriate Term/Code Not Available 943 943
Corroded 840 840
Failure to Calibrate 736 736
Incorrect, Inadequate or Imprecise Result or Readings 661 661
Computer Software Problem 517 517
Device Alarm System 494 494
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 298 298
Insufficient Information 293 293
Circuit Failure 281 281
Output Problem 215 215
Device Sensing Problem 184 184
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 49 49
Unable to Obtain Readings 47 47
Incorrect Measurement 38 38
Peeled/Delaminated 36 36
Failure to Power Up 36 36
Pumping Stopped 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 18 18
Device Operates Differently Than Expected 16 16
Image Display Error/Artifact 15 15
Mechanical Problem 13 13
Device Displays Incorrect Message 13 13
Device Markings/Labelling Problem 12 12
Erratic or Intermittent Display 12 12
False Alarm 12 12
No Audible Alarm 12 12
Use of Device Problem 11 11
Failure to Sense 10 10
Defective Alarm 10 10
No Display/Image 10 10
Defective Device 10 10
Device Stops Intermittently 10 10
Noise, Audible 10 10
Unexpected Shutdown 9 9
Obstruction of Flow 9 9
Device Ingredient or Reagent Problem 8 8
Mechanics Altered 8 8
Component Missing 7 7
Failure to Deliver 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Device Inoperable 6 6
Smoking 6 6
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Device Operational Issue 5 5
Invalid Sensing 5 5
Device Damaged Prior to Use 5 5
Device Issue 5 5
Charging Problem 5 5
Partial Blockage 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Protective Measures Problem 4 4
Intermittent Loss of Power 4 4
Data Problem 4 4
Component Misassembled 4 4
Disconnection 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Failure to Align 4 4
Electrical Power Problem 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 4 4
Infusion or Flow Problem 4 4
Filtration Problem 4 4
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Inappropriate or Unexpected Reset 3 3
Moisture or Humidity Problem 3 3
Pressure Problem 3 3
No Audible Prompt/Feedback 3 3
Sparking 3 3
Computer Operating System Problem 3 3
Device Emits Odor 3 3
Overheating of Device 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5384 5384
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
No Information 88 88
Insufficient Information 88 88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Unintended Extubation 5 5
Foreign Body In Patient 3 3
Low Oxygen Saturation 3 3
Cardiac Arrest 3 3
Hypoxia 2 2
Death 2 2
Respiratory Distress 2 2
Unspecified Tissue Injury 2 2
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Partial thickness (Second Degree) Burn 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
Laceration(s) 1 1
Pain 1 1
Perforation 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 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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