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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
  1.  K213518  CARESCAPE CO2 Microstream parameter
  2.  K213911  Microstream CO2 NanoPod
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K213518  CARESCAPE CO2 Microstream parameter
  2.  K213911  Microstream CO2 NanoPod
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 2
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
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 63 63
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1638 1638
2024 1089 1089

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3344 3344
Communication or Transmission Problem 2591 2591
Crack 2335 2335
Corroded 978 978
Appropriate Term/Code Not Available 944 944
Failure to Calibrate 897 897
Incorrect, Inadequate or Imprecise Result or Readings 733 733
Device Alarm System 629 629
Computer Software Problem 564 564
Contamination 527 527
Failure of Device to Self-Test 478 478
No Device Output 467 467
Loose or Intermittent Connection 417 417
No Apparent Adverse Event 413 413
Calibration Problem 379 379
Circuit Failure 300 300
Insufficient Information 295 295
Output Problem 218 218
Device Sensing Problem 180 180
Physical Resistance/Sticking 119 119
Failure to Read Input Signal 109 109
Display Difficult to Read 77 77
Display or Visual Feedback Problem 74 74
Application Program Freezes, Becomes Nonfunctional 62 62
Unable to Obtain Readings 57 57
Incorrect Measurement 55 55
Misassembled 49 49
Low Readings 45 45
High Readings 40 40
Failure to Power Up 39 39
Peeled/Delaminated 38 38
Pumping Stopped 37 37
Missing Information 31 31
Naturally Worn 28 28
Degraded 28 28
Application Program Problem 27 27
Failure to Cycle 25 25
Electrical /Electronic Property Problem 24 24
Power Problem 22 22
Gas Output Problem 20 20
Temperature Problem 20 20
Image Display Error/Artifact 19 19
Mechanical Problem 18 18
No Display/Image 17 17
Device Markings/Labelling Problem 15 15
Erratic or Intermittent Display 14 14
Noise, Audible 13 13
Unexpected Shutdown 13 13
False Alarm 12 12
Use of Device Problem 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6751 6751
No Patient Involvement 2990 2990
No Consequences Or Impact To Patient 132 132
Insufficient Information 122 122
No Known Impact Or Consequence To Patient 114 114
No Information 81 81
Unintended Extubation 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Cardiac Arrest 4 4
Unspecified Tissue Injury 4 4
Foreign Body In Patient 3 3
Low Oxygen Saturation 3 3
Death 2 2
Respiratory Distress 2 2
Pain 2 2
Hypoxia 2 2
Cyanosis 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoventilation 1 1
Respiratory Arrest 1 1
Perforation 1 1
Injury 1 1
Chest Pain 1 1
Discomfort 1 1
Cardiopulmonary Arrest 1 1
Laceration(s) 1 1
Anxiety 1 1
Cough 1 1
Pressure Sores 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Respiratory Insufficiency 1 1
Bruise/Contusion 1 1
Lethargy 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 Nihon Kohden America Inc II Nov-06-2024
5 Oridion Medical 1987 Ltd. II Oct-03-2018
6 Smiths Medical ASD Inc. II Jul-06-2018
7 Southmedic, Inc. II Jul-24-2021
8 Southmedic, Inc. II Jan-25-2018
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