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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
ENGINEERED MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K220533  Endoscopy Oxygen Mask
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
2023 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2116 2116
Communication or Transmission Problem 1569 1569
Crack 1440 1440
Appropriate Term/Code Not Available 940 940
Corroded 684 684
Failure to Calibrate 672 672
Incorrect, Inadequate or Imprecise Result or Readings 565 565
Contamination 486 486
Device Alarm System 457 457
Failure of Device to Self-Test 451 451
No Device Output 390 390
No Apparent Adverse Event 382 382
Computer Software Problem 342 342
Insufficient Information 274 274
Circuit Failure 271 271
Calibration Problem 251 251
Loose or Intermittent Connection 220 220
Output Problem 204 204
Device Sensing Problem 183 183
Failure to Read Input Signal 104 104
Physical Resistance/Sticking 79 79
Display or Visual Feedback Problem 70 70
Display Difficult to Read 58 58
Application Program Freezes, Becomes Nonfunctional 57 57
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
Naturally Worn 26 26
Degraded 25 25
Application Program Problem 25 25
Failure to Cycle 25 25
High Readings 24 24
Low Readings 23 23
Electrical /Electronic Property Problem 21 21
Power Problem 20 20
Gas Output Problem 18 18
Temperature Problem 16 16
Device Operates Differently Than Expected 16 16
Image Display Error/Artifact 15 15
Mechanical Problem 13 13
Device Displays Incorrect Message 13 13
No Audible Alarm 12 12
Device Markings/Labelling Problem 11 11
Erratic or Intermittent Display 11 11
Use of Device Problem 10 10
Defective Device 10 10
Noise, Audible 10 10
False Alarm 10 10
Device Stops Intermittently 10 10
No Display/Image 9 9
Mechanics Altered 8 8
Failure to Sense 8 8
Application Program Version or Upgrade Problem 7 7
Unexpected Shutdown 7 7
Battery Problem 7 7
Defective Alarm 7 7
Obstruction of Flow 7 7
Failure to Deliver 7 7
Component Missing 6 6
Smoking 6 6
Defective Component 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Device Inoperable 6 6
Partial Blockage 5 5
Charging Problem 5 5
Inaccurate Information 5 5
Device Operational Issue 5 5
Device Issue 5 5
Device Damaged Prior to Use 5 5
Invalid Sensing 5 5
Electrical Power Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 4 4
Filtration Problem 4 4
Nonstandard Device 4 4
Infusion or Flow Problem 4 4
Intermittent Loss of Power 4 4
Protective Measures Problem 4 4
Device Ingredient or Reagent Problem 4 4
Data Problem 4 4
Sensing Intermittently 4 4
Pressure Problem 3 3
Computer Operating System Problem 3 3
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Sparking 3 3
Material Fragmentation 3 3
Device Emits Odor 3 3
Overheating of Device 3 3
Component Misassembled 3 3
Intermittent Communication Failure 3 3
Inappropriate or Unexpected Reset 3 3
Moisture or Humidity Problem 3 3
No Audible Prompt/Feedback 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 4157 4157
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
Cardiac Arrest 3 3
Low Oxygen Saturation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body In Patient 2 2
Death 2 2
Hypoxia 2 2
Unspecified Tissue Injury 2 2
Respiratory Distress 2 2
Injury 1 1
Burn, Thermal 1 1
Chest Pain 1 1
Laceration(s) 1 1
Pain 1 1
Pressure Sores 1 1
Lethargy 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Unintended Extubation 1 1
Cardiopulmonary Arrest 1 1
Perforation 1 1
Inadequate Pain Relief 1 1
Death, Intrauterine Fetal 1 1
Patient Problem/Medical Problem 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Cyanosis 1 1
Hypersensitivity/Allergic reaction 1 1
Extubate 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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