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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
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
SOUTHMEDIC 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 1637 1637
2024 212 212

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3145 3145
Communication or Transmission Problem 2134 2134
Crack 2131 2131
Appropriate Term/Code Not Available 943 943
Corroded 875 875
Failure to Calibrate 785 785
Incorrect, Inadequate or Imprecise Result or Readings 716 716
Computer Software Problem 564 564
Device Alarm System 541 541
Contamination 498 498
Failure of Device to Self-Test 465 465
No Device Output 451 451
No Apparent Adverse Event 406 406
Loose or Intermittent Connection 372 372
Calibration Problem 344 344
Circuit Failure 295 295
Insufficient Information 293 293
Output Problem 217 217
Device Sensing Problem 184 184
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 105 105
Display Difficult to Read 75 75
Display or Visual Feedback Problem 72 72
Application Program Freezes, Becomes Nonfunctional 61 61
Misassembled 49 49
Unable to Obtain Readings 48 48
Incorrect Measurement 41 41
Failure to Power Up 37 37
Pumping Stopped 37 37
Peeled/Delaminated 36 36
Low Readings 31 31
High Readings 29 29
Naturally Worn 28 28
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 19 19
Mechanical Problem 19 19
Temperature Problem 18 18
Image Display Error/Artifact 17 17
Device Operates Differently Than Expected 16 16
Device Displays Incorrect Message 13 13
Erratic or Intermittent Display 13 13
No Display/Image 13 13
False Alarm 12 12
No Audible Alarm 12 12
Device Markings/Labelling Problem 12 12
Use of Device Problem 11 11
Noise, Audible 11 11
Defective Device 10 10
Defective Alarm 10 10
Device Stops Intermittently 10 10
Failure to Sense 10 10
Obstruction of Flow 9 9
Unexpected Shutdown 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
Smoking 6 6
Device Damaged Prior to Use 6 6
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Device Inoperable 6 6
Material Split, Cut or Torn 6 6
Data Problem 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Partial Blockage 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Charging Problem 5 5
Device Operational Issue 5 5
Invalid Sensing 5 5
Device Issue 5 5
Failure to Align 5 5
Deformation Due to Compressive Stress 4 4
Inaccurate Delivery 4 4
No Audible Prompt/Feedback 4 4
Detachment of Device or Device Component 4 4
Electrical Power Problem 4 4
Infusion or Flow Problem 4 4
Filtration Problem 4 4
Protective Measures Problem 4 4
Disconnection 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Component Misassembled 4 4
Intermittent Loss of Power 4 4
Unintended Application Program Shut Down 3 3
Intermittent Communication Failure 3 3
Unclear Information 3 3
Missing Information 3 3
Device Emits Odor 3 3
Overheating of Device 3 3
Failure to Analyze Signal 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5898 5898
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 103 103
No Information 88 88
Unintended Extubation 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
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
Partial thickness (Second Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Death, Intrauterine Fetal 1 1
Hypersensitivity/Allergic reaction 1 1
Burn, Thermal 1 1
Lethargy 1 1
Pressure Sores 1 1
Anxiety 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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