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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
CAIRE INC.
  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 2
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
  1.  K211056  Oxus Sieve Beds
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 267 267

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 166 166
Overheating of Device 152 152
Fire 150 150
Low Readings 107 107
Thermal Decomposition of Device 93 93
Insufficient Information 90 94
Use of Device Problem 86 86
No Flow 82 82
No Audible Alarm 71 71
Output Problem 57 57
Temperature Problem 56 56
Explosion 49 49
Melted 44 44
Electrical /Electronic Property Problem 43 43
Unexpected Shutdown 41 41
Noise, Audible 40 40
Smoking 37 37
Device Emits Odor 35 35
Insufficient Flow or Under Infusion 35 35
Excessive Heating 31 31
Improper or Incorrect Procedure or Method 30 30
Power Problem 29 29
Material Deformation 29 29
Battery Problem 29 29
Contamination 29 29
No Apparent Adverse Event 26 26
Gas Output Problem 26 26
Infusion or Flow Problem 24 24
Mechanical Problem 23 23
Failure to Deliver 22 22
Device Alarm System 20 20
Crack 20 20
Failure to Power Up 20 20
Particulates 19 19
Improper Flow or Infusion 19 19
Degraded 18 18
Appropriate Term/Code Not Available 16 16
Sparking 16 16
Gas/Air Leak 14 14
Device Contamination with Chemical or Other Material 13 13
Unexpected Therapeutic Results 13 13
Failure to Charge 12 12
Material Integrity Problem 11 11
Complete Loss of Power 11 11
Electrical Shorting 11 11
Therapeutic or Diagnostic Output Failure 10 10
Disconnection 10 10
Defective Alarm 10 10
Intermittent 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 901 905
Low Oxygen Saturation 131 131
Burn(s) 127 127
Insufficient Information 118 118
Dyspnea 85 85
No Consequences Or Impact To Patient 72 72
Hypoxia 68 68
Unspecified Respiratory Problem 53 53
Partial thickness (Second Degree) Burn 49 49
Death 44 44
Chronic Obstructive Pulmonary Disease (COPD) 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
No Known Impact Or Consequence To Patient 24 24
Full thickness (Third Degree) Burn 20 20
Superficial (First Degree) Burn 19 19
No Patient Involvement 16 16
Headache 12 12
Pneumonia 11 11
Swelling/ Edema 10 10
Patient Problem/Medical Problem 9 9
Aspiration/Inhalation 9 9
Skin Inflammation/ Irritation 9 9
Dizziness 9 9
Pain 8 8
Hypersensitivity/Allergic reaction 8 8
No Information 6 6
Discomfort 6 6
Distress 6 6
Unspecified Heart Problem 5 5
Inflammation 5 5
Unspecified Kidney or Urinary Problem 5 5
Muscle Weakness 5 5
Respiratory Tract Infection 5 5
Erythema 5 5
Respiratory Failure 5 5
Burning Sensation 5 5
Heart Failure/Congestive Heart Failure 4 4
Cough 4 4
Fall 4 4
Loss of consciousness 4 4
Respiratory Insufficiency 4 4
Cognitive Changes 4 4
Viral Infection 4 4
Sleep Dysfunction 4 4
Anxiety 3 3
Myocardial Infarction 3 3
Laceration(s) 3 3
Bruise/Contusion 3 3
Increased Sensitivity 3 3
Confusion/ Disorientation 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
11 Medical Depot Inc. I May-09-2025
12 Ohio Medical Corporation II Jun-13-2025
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