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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
  1.  K180902  MediPines Gas Exchange Monitor (GEM), Accessory Mo ...
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 1597 1597

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3006 3006
Crack 2046 2046
Communication or Transmission Problem 2010 2010
Appropriate Term/Code Not Available 943 943
Corroded 847 847
Failure to Calibrate 758 758
Incorrect, Inadequate or Imprecise Result or Readings 692 692
Computer Software Problem 564 564
Device Alarm System 515 515
Contamination 492 492
Failure of Device to Self-Test 461 461
No Device Output 441 441
No Apparent Adverse Event 404 404
Loose or Intermittent Connection 361 361
Calibration Problem 323 323
Insufficient Information 293 293
Circuit Failure 285 285
Output Problem 216 216
Device Sensing Problem 184 184
Physical Resistance/Sticking 111 111
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 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
Electrical /Electronic Property Problem 22 22
Power Problem 22 22
Temperature Problem 18 18
Gas Output Problem 18 18
Image Display Error/Artifact 17 17
Device Operates Differently Than Expected 16 16
Mechanical Problem 15 15
Erratic or Intermittent Display 13 13
Device Displays Incorrect Message 13 13
Device Markings/Labelling Problem 12 12
False Alarm 12 12
No Audible Alarm 12 12
No Display/Image 11 11
Use of Device Problem 11 11
Noise, Audible 11 11
Failure to Sense 10 10
Defective Alarm 10 10
Defective Device 10 10
Device Stops Intermittently 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
Device Inoperable 6 6
Smoking 6 6
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Material Split, Cut or Torn 6 6
Suction Failure 5 5
Inaccurate Information 5 5
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
Failure to Align 5 5
Charging Problem 5 5
Partial Blockage 5 5
Disconnection 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Inaccurate Delivery 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
Intermittent Loss of Power 4 4
Protective Measures Problem 4 4
Component Misassembled 4 4
Data Problem 4 4
Intermittent Communication Failure 3 3
Missing Information 3 3
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Inappropriate or Unexpected Reset 3 3
Pressure Problem 3 3
Moisture or Humidity Problem 3 3
No Audible Prompt/Feedback 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5660 5660
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 94 94
No Information 88 88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unintended Extubation 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
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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