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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 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
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 2303 2303
2021 2272 2272
2022 2476 2476
2023 642 642

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2455 2455
Communication or Transmission Problem 1703 1703
Crack 1512 1512
Appropriate Term/Code Not Available 940 940
Corroded 745 745
Failure to Calibrate 708 708
Incorrect, Inadequate or Imprecise Result or Readings 605 605
Contamination 488 488
Device Alarm System 477 477
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 282 282
Circuit Failure 273 273
Loose or Intermittent Connection 244 244
Output Problem 211 211
Device Sensing Problem 184 184
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 49 49
Unable to Obtain Readings 46 46
Incorrect Measurement 39 39
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
Application Program Problem 25 25
High Readings 25 25
Failure to Cycle 25 25
Electrical /Electronic Property Problem 21 21
Power Problem 20 20
Gas Output Problem 18 18
Temperature Problem 17 17
Device Operates Differently Than Expected 16 16
Image Display Error/Artifact 15 15
Mechanical Problem 13 13
Device Displays Incorrect Message 13 13
Device Markings/Labelling Problem 12 12
False Alarm 12 12
No Audible Alarm 12 12
Erratic or Intermittent Display 11 11
Failure to Sense 10 10
Device Stops Intermittently 10 10
Defective Device 10 10
Use of Device Problem 10 10
Noise, Audible 10 10
No Display/Image 9 9
Defective Alarm 8 8
Mechanics Altered 8 8
Obstruction of Flow 7 7
Component Missing 7 7
Failure to Deliver 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Unexpected Shutdown 7 7
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Device Inoperable 6 6
Smoking 6 6
Partial Blockage 5 5
Device Operational Issue 5 5
Charging Problem 5 5
Invalid Sensing 5 5
Device Damaged Prior to Use 5 5
Device Issue 5 5
Inaccurate Information 5 5
Intermittent Loss of Power 4 4
Component Misassembled 4 4
Data Problem 4 4
Intermittent Communication Failure 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
Infusion or Flow Problem 4 4
Filtration Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Protective Measures Problem 4 4
Disconnection 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
Pressure Problem 3 3
Moisture or Humidity Problem 3 3
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Inappropriate or Unexpected Reset 3 3
Sparking 3 3
Computer Operating System Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4723 4723
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 147 147
No Consequences Or Impact To Patient 143 143
No Information 88 88
Insufficient Information 84 84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Low Oxygen Saturation 3 3
Cardiac Arrest 3 3
Hypoxia 2 2
Death 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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