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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
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213518  CARESCAPE CO2 Microstream parameter
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
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 1412 1412

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1632 1632
Crack 1387 1387
Communication or Transmission Problem 1199 1199
Appropriate Term/Code Not Available 940 940
Failure to Calibrate 605 605
Corroded 509 509
Incorrect, Inadequate or Imprecise Resultor Readings 491 491
Contamination 485 485
Failure of Device to Self-Test 449 449
No Device Output 378 378
No Apparent Adverse Event 370 370
Device Alarm System 360 360
Computer Software Problem 334 334
Insufficient Information 259 259
Circuit Failure 248 248
Output Problem 191 191
Loose or Intermittent Connection 187 187
Device Sensing Problem 182 182
Calibration Problem 166 166
Failure to Read Input Signal 102 102
Display or Visual Feedback Problem 67 67
Application Program Freezes, Becomes Nonfunctional 56 56
Misassembled 49 49
Physical Resistance/Sticking 43 43
Unable to Obtain Readings 37 37
Pumping Stopped 36 36
Display Difficult to Read 35 35
Incorrect Measurement 33 33
Peeled/Delaminated 31 31
Failure to Power Up 30 30
Failure to Cycle 25 25
Degraded 24 24
Naturally Worn 23 23
Application Program Problem 22 22
Electrical /Electronic Property Problem 20 20
Low Readings 19 19
High Readings 18 18
Power Problem 17 17
Device Operates Differently Than Expected 16 16
Gas Output Problem 16 16
Temperature Problem 13 13
Device Displays Incorrect Message 12 12
No Audible Alarm 12 12
Image Display Error/Artifact 11 11
Device Markings/Labelling Problem 11 11
Device Stops Intermittently 10 10
Use of Device Problem 10 10
Erratic or Intermittent Display 9 9
False Alarm 8 8
Mechanics Altered 8 8
Application Program Version or Upgrade Problem 7 7
Failure to Deliver 7 7
Mechanical Problem 7 7
Defective Alarm 6 6
Device Inoperable 6 6
Smoking 6 6
Material Deformation 6 6
Noise, Audible 6 6
Material Integrity Problem 5 5
Device Operational Issue 5 5
Invalid Sensing 5 5
Component Missing 5 5
Device Damaged Prior to Use 5 5
Device Issue 5 5
Defective Device 5 5
Charging Problem 5 5
Failure to Sense 5 5
Partial Blockage 5 5
No Display/Image 5 5
Sensing Intermittently 4 4
Nonstandard Device 4 4
Detachment of Device or Device Component 4 4
Battery Problem 4 4
Defective Component 4 4
Deformation Due to Compressive Stress 4 4
Electrical Power Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Protective Measures Problem 4 4
Unexpected Shutdown 4 4
Intermittent Loss of Power 3 3
Data Problem 3 3
Intermittent Communication Failure 3 3
Inaccurate Information 3 3
Moisture or Humidity 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
Fluid Leak 2 2
Excess Flow or Over-Infusion 2 2
Application Program Problem: Dose Calculation Error 2 2
Failure to Charge 2 2
Self-Activation or Keying 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3013 3013
No Patient Involvement 3003 3003
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
Foreign Body In Patient 2 2
Death 2 2
Hypoxia 2 2
Unspecified Tissue Injury 2 2
Respiratory Distress 2 2
Injury 1 1
Burn, Thermal 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Laceration(s) 1 1
Pain 1 1
Pressure Sores 1 1
Lethargy 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Cardiopulmonary Arrest 1 1
Perforation 1 1
Inadequate Pain Relief 1 1
Death, Intrauterine Fetal 1 1
Patient Problem/Medical Problem 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cyanosis 1 1
Hypersensitivity/Allergic reaction 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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