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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
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K192563  Altera gas Sampling Lines
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 910 910

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2636 2636
Communication or Transmission Problem 1768 1768
Crack 1557 1557
Appropriate Term/Code Not Available 943 943
Corroded 765 765
Failure to Calibrate 714 714
Incorrect, Inadequate or Imprecise Result or Readings 619 619
Contamination 489 489
Device Alarm System 485 485
Failure of Device to Self-Test 455 455
Computer Software Problem 440 440
No Device Output 410 410
No Apparent Adverse Event 395 395
Insufficient Information 292 292
Calibration Problem 286 286
Circuit Failure 278 278
Loose or Intermittent Connection 258 258
Output Problem 211 211
Device Sensing Problem 184 184
Failure to Read Input Signal 105 105
Physical Resistance/Sticking 98 98
Display Difficult to Read 72 72
Display or Visual Feedback Problem 71 71
Application Program Freezes, Becomes Nonfunctional 60 60
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 21 21
Temperature Problem 18 18
Gas Output Problem 18 18
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
No Display/Image 10 10
Failure to Sense 10 10
Device Stops Intermittently 10 10
Defective Device 10 10
Use of Device Problem 10 10
Noise, Audible 10 10
Defective Alarm 9 9
Obstruction of Flow 8 8
Mechanics Altered 8 8
Unexpected Shutdown 8 8
Device Ingredient or Reagent Problem 7 7
Component Missing 7 7
Failure to Deliver 7 7
Application Program Version or Upgrade Problem 7 7
Battery Problem 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
Adverse Event Without Identified Device or Use Problem 5 5
Charging Problem 5 5
Device Operational Issue 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
Failure to Align 4 4
Deformation Due to Compressive Stress 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4983 4983
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 85 85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Unintended Extubation 4 4
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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