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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
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
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 2303 2303
2021 2272 2272
2022 2476 2476
2023 642 642

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2454 2454
Communication or Transmission Problem 1703 1703
Crack 1512 1512
Appropriate Term/Code Not Available 940 940
Corroded 745 745
Failure to Calibrate 707 707
Incorrect, Inadequate or Imprecise Result or Readings 601 601
Contamination 488 488
Device Alarm System 475 475
Failure of Device to Self-Test 455 455
Computer Software Problem 407 407
No Device Output 406 406
No Apparent Adverse Event 392 392
Insufficient Information 290 290
Calibration Problem 278 278
Circuit Failure 273 273
Loose or Intermittent Connection 244 244
Output Problem 209 209
Device Sensing Problem 180 180
Failure to Read Input Signal 105 105
Physical Resistance/Sticking 95 95
Display or Visual Feedback Problem 71 71
Display Difficult to Read 65 65
Application Program Freezes, Becomes Nonfunctional 59 59
Misassembled 48 48
Unable to Obtain Readings 44 44
Incorrect Measurement 38 38
Peeled/Delaminated 36 36
Failure to Power Up 36 36
Pumping Stopped 36 36
Degraded 27 27
Naturally Worn 27 27
Low Readings 27 27
High Readings 25 25
Application Program Problem 25 25
Failure to Cycle 25 25
Electrical /Electronic Property Problem 21 21
Power Problem 20 20
Gas Output Problem 18 18
Temperature Problem 16 16
Image Display Error/Artifact 15 15
False Alarm 12 12
Mechanical Problem 12 12
Device Markings/Labelling Problem 12 12
Erratic or Intermittent Display 11 11
Device Displays Incorrect Message 10 10
Noise, Audible 10 10
Defective Device 9 9
No Display/Image 9 9
Use of Device Problem 9 9
Failure to Sense 8 8
Mechanics Altered 8 8
Obstruction of Flow 7 7
Component Missing 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Defective Alarm 7 7
Unexpected Shutdown 7 7
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 5 5
Failure to Deliver 5 5
Device Damaged Prior to Use 5 5
Device Issue 5 5
Charging Problem 5 5
No Audible Alarm 5 5
Inaccurate Information 5 5
Intermittent Communication Failure 4 4
Intermittent Loss of Power 4 4
Component Misassembled 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Detachment of Device or Device Component 4 4
Device Ingredient or Reagent Problem 4 4
Invalid Sensing 4 4
Deformation Due to Compressive Stress 4 4
Infusion or Flow Problem 4 4
Electrical Power Problem 4 4
Filtration Problem 4 4
Protective Measures Problem 4 4
Data Problem 4 4
Inappropriate or Unexpected Reset 3 3
Pressure Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Gas/Air Leak 3 3
Device Operates Differently Than Expected 3 3
Device Operational Issue 3 3
Moisture or Humidity Problem 3 3
No Audible Prompt/Feedback 3 3
Failure to Align 3 3
Computer Operating System Problem 3 3
Sparking 3 3
Device Emits Odor 3 3
Failure to Analyze Signal 3 3
Smoking 3 3
Device Stops Intermittently 3 3
Partial Blockage 3 3
Disconnection 3 3
Material Fragmentation 3 3
Excess Flow or Over-Infusion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4721 4721
No Patient Involvement 2990 2990
No Consequences Or Impact To Patient 132 132
No Known Impact Or Consequence To Patient 115 115
Insufficient Information 84 84
No Information 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cardiac Arrest 3 3
Respiratory Distress 2 2
Death 2 2
Foreign Body In Patient 2 2
Unspecified Tissue Injury 2 2
Respiratory Arrest 1 1
Cyanosis 1 1
Extubate 1 1
Laceration(s) 1 1
Unintended Extubation 1 1
Lethargy 1 1
Superficial (First Degree) Burn 1 1
Chest Pain 1 1
Pain 1 1
Injury 1 1
Cardiopulmonary Arrest 1 1
Perforation 1 1
Pressure Sores 1 1
Hypersensitivity/Allergic reaction 1 1
Low Oxygen Saturation 1 1
Respiratory Insufficiency 1 1
Hypoxia 1 1
Inadequate Pain Relief 1 1
Patient Problem/Medical Problem 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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