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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, oxygen, portable
Regulation Description Portable oxygen generator.
Product CodeCAW
Regulation Number 868.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
3B MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BELLUSCURA LLC
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN MIC MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INOGEN
  SUBSTANTIALLY EQUIVALENT 1
INOGEN, INC
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  1.  K191159  Concentrator with Single battery pack, carry bag w ...
  2.  K200890  Invacare Perfecto2V Oxygen Concentrator
  3.  K203210  Invacare Platinum 5NXG Oxygen Concentrator
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LONGFIAN SCITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOLECULAR PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 120 120
2020 125 125
2021 194 194
2022 305 305
2023 357 361
2024 450 450
2025 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 145 145
Fire 143 143
Overheating of Device 136 136
Low Readings 107 107
Insufficient Information 81 85
Use of Device Problem 79 79
Thermal Decomposition of Device 77 77
No Audible Alarm 71 71
Explosion 49 49
Temperature Problem 48 48
No Flow 44 44
Melted 42 42
Electrical /Electronic Property Problem 37 37
Noise, Audible 37 37
Unexpected Shutdown 36 36
Smoking 34 34
Insufficient Flow or Under Infusion 30 30
Material Deformation 29 29
Improper or Incorrect Procedure or Method 27 27
Battery Problem 27 27
Device Emits Odor 25 25
Contamination 25 25
Excessive Heating 25 25
Power Problem 25 25
Gas Output Problem 22 22
Infusion or Flow Problem 22 22
Failure to Deliver 22 22
Output Problem 22 22
Mechanical Problem 21 21
Device Alarm System 20 20
Crack 20 20
No Apparent Adverse Event 20 20
Particulates 19 19
Failure to Power Up 18 18
Degraded 18 18
Improper Flow or Infusion 17 17
Sparking 15 15
Gas/Air Leak 14 14
Appropriate Term/Code Not Available 12 12
Device Contamination with Chemical or Other Material 12 12
Failure to Charge 12 12
Material Integrity Problem 11 11
Disconnection 10 10
Electrical Shorting 10 10
Therapeutic or Diagnostic Output Failure 10 10
Defective Alarm 10 10
Intermittent Loss of Power 9 9
Break 9 9
Material Discolored 9 9
Complete Loss of Power 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 822 826
Low Oxygen Saturation 120 120
Burn(s) 115 115
Insufficient Information 101 101
No Consequences Or Impact To Patient 72 72
Partial thickness (Second Degree) Burn 45 45
Death 44 44
Unspecified Respiratory Problem 43 43
Dyspnea 42 42
Hypoxia 30 30
No Known Impact Or Consequence To Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Full thickness (Third Degree) Burn 20 20
Superficial (First Degree) Burn 18 18
No Patient Involvement 16 16
Headache 12 12
Pneumonia 11 11
Patient Problem/Medical Problem 9 9
Dizziness 9 9
Aspiration/Inhalation 9 9
Skin Inflammation/ Irritation 9 9
Pain 8 8
Hypersensitivity/Allergic reaction 8 8
Swelling/ Edema 8 8
Distress 6 6
No Information 6 6
Discomfort 6 6
Unspecified Heart Problem 5 5
Muscle Weakness 5 5
Respiratory Tract Infection 5 5
Burning Sensation 5 5
Inflammation 5 5
Erythema 5 5
Unspecified Kidney or Urinary Problem 5 5
Respiratory Insufficiency 4 4
Cognitive Changes 4 4
Fall 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Viral Infection 4 4
Respiratory Distress 3 3
Arthralgia 3 3
Cough 3 3
Loss of consciousness 3 3
Itching Sensation 3 3
Confusion/ Disorientation 3 3
Emotional Changes 3 3
Cyanosis 3 3
Respiratory Arrest 3 3
Increased Sensitivity 3 3
Bruise/Contusion 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. II Nov-15-2024
2 Caire, Inc. II May-19-2022
3 Caire, Inc. II Jan-13-2020
4 Caire, Inc. II Oct-30-2019
5 DeVilbiss Healthcare LLC II May-04-2023
6 DeVilbiss Healthcare LLC II Dec-19-2022
7 DeVilbiss Healthcare LLC II Nov-11-2022
8 Invacare Corporation III Jul-12-2022
9 Invacare Corporation II Dec-01-2020
10 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD I Jan-03-2025
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