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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
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
  1.  K213825  Oxygen Concentrator model 8F-3A, Oxygen Concentrat ...
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 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 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 154 154
Fire 144 144
Overheating of Device 138 138
Low Readings 107 107
Insufficient Information 87 91
Use of Device Problem 83 83
Thermal Decomposition of Device 81 81
No Audible Alarm 71 71
No Flow 61 61
Output Problem 57 57
Temperature Problem 50 50
Explosion 49 49
Melted 42 42
Noise, Audible 39 39
Electrical /Electronic Property Problem 39 39
Unexpected Shutdown 36 36
Smoking 35 35
Insufficient Flow or Under Infusion 32 32
Device Emits Odor 30 30
Excessive Heating 29 29
Material Deformation 29 29
Battery Problem 29 29
Improper or Incorrect Procedure or Method 27 27
Power Problem 27 27
Contamination 27 27
Gas Output Problem 25 25
Mechanical Problem 23 23
Infusion or Flow Problem 23 23
Failure to Deliver 22 22
No Apparent Adverse Event 21 21
Device Alarm System 20 20
Crack 20 20
Failure to Power Up 20 20
Particulates 19 19
Improper Flow or Infusion 18 18
Degraded 18 18
Appropriate Term/Code Not Available 16 16
Sparking 15 15
Gas/Air Leak 14 14
Device Contamination with Chemical or Other Material 12 12
Failure to Charge 12 12
Material Integrity Problem 11 11
Therapeutic or Diagnostic Output Failure 10 10
Disconnection 10 10
Defective Alarm 10 10
Electrical Shorting 10 10
Intermittent Loss of Power 9 9
Material Discolored 9 9
Complete Loss of Power 9 9
Break 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 843 847
Burn(s) 122 122
Low Oxygen Saturation 121 121
Insufficient Information 107 107
No Consequences Or Impact To Patient 72 72
Dyspnea 68 68
Hypoxia 50 50
Unspecified Respiratory Problem 48 48
Partial thickness (Second Degree) Burn 48 48
Death 44 44
No Known Impact Or Consequence To Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Chronic Obstructive Pulmonary Disease (COPD) 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
Swelling/ Edema 10 10
Patient Problem/Medical Problem 9 9
Dizziness 9 9
Skin Inflammation/ Irritation 9 9
Aspiration/Inhalation 9 9
Pain 8 8
Hypersensitivity/Allergic reaction 8 8
Discomfort 6 6
Distress 6 6
No Information 6 6
Respiratory Tract Infection 5 5
Unspecified Kidney or Urinary Problem 5 5
Erythema 5 5
Burning Sensation 5 5
Inflammation 5 5
Muscle Weakness 5 5
Unspecified Heart Problem 5 5
Fall 4 4
Viral Infection 4 4
Heart Failure/Congestive Heart Failure 4 4
Cough 4 4
Cognitive Changes 4 4
Respiratory Insufficiency 4 4
Sleep Dysfunction 4 4
Myocardial Infarction 3 3
Itching Sensation 3 3
Confusion/ Disorientation 3 3
Loss of consciousness 3 3
Epistaxis 3 3
Respiratory Arrest 3 3
Respiratory Distress 3 3
Fatigue 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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