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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
  1.  K170820  Capnograph and Oximeter
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
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 2306 2306
2021 2272 2272
2022 2476 2476

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2086 2086
Communication or Transmission Problem 1558 1558
Crack 1431 1431
Appropriate Term/Code Not Available 940 940
Failure to Calibrate 670 670
Corroded 669 669
Incorrect, Inadequate or Imprecise Result or Readings 555 555
Contamination 486 486
Device Alarm System 452 452
Failure of Device to Self-Test 451 451
No Device Output 389 389
No Apparent Adverse Event 379 379
Computer Software Problem 342 342
Insufficient Information 274 274
Circuit Failure 270 270
Calibration Problem 238 238
Loose or Intermittent Connection 218 218
Output Problem 202 202
Device Sensing Problem 183 183
Failure to Read Input Signal 104 104
Physical Resistance/Sticking 78 78
Display or Visual Feedback Problem 70 70
Display Difficult to Read 57 57
Application Program Freezes, Becomes Nonfunctional 56 56
Misassembled 49 49
Unable to Obtain Readings 44 44
Incorrect Measurement 38 38
Pumping Stopped 36 36
Failure to Power Up 35 35
Peeled/Delaminated 33 33
Failure to Cycle 25 25
Degraded 25 25
Naturally Worn 25 25
Application Program Problem 25 25
High Readings 24 24
Low Readings 22 22
Electrical /Electronic Property Problem 21 21
Power Problem 20 20
Gas Output Problem 18 18
Device Operates Differently Than Expected 16 16
Temperature Problem 15 15
Image Display Error/Artifact 15 15
Mechanical Problem 13 13
No Audible Alarm 12 12
Device Displays Incorrect Message 12 12
Device Markings/Labelling Problem 11 11
Erratic or Intermittent Display 11 11
False Alarm 10 10
Device Stops Intermittently 10 10
Defective Device 10 10
Use of Device Problem 10 10
Noise, Audible 10 10
Mechanics Altered 8 8
Failure to Sense 8 8
No Display/Image 8 8
Defective Alarm 7 7
Obstruction of Flow 7 7
Failure to Deliver 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Unexpected Shutdown 7 7
Component Missing 6 6
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Smoking 6 6
Device Inoperable 6 6
Partial Blockage 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
Inaccurate Information 5 5
Protective Measures Problem 4 4
Intermittent Loss of Power 4 4
Data Problem 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 4 4
Device Ingredient or Reagent Problem 4 4
Electrical Power Problem 4 4
Filtration Problem 4 4
Infusion or Flow Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Material Fragmentation 3 3
Overheating of Device 3 3
Device Emits Odor 3 3
Failure to Analyze Signal 3 3
Disconnection 3 3
Pressure Problem 3 3
Moisture or Humidity Problem 3 3
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Computer Operating System Problem 3 3
Sparking 3 3
No Audible Prompt/Feedback 3 3
Component Misassembled 3 3
Intermittent Communication Failure 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4074 4074
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 81 81
Low Oxygen Saturation 3 3
Cardiac Arrest 3 3
Hypoxia 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
Respiratory Distress 2 2
Foreign Body In Patient 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
Unintended Extubation 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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