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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
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 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 152 152
Fire 143 143
Overheating of Device 136 136
Low Readings 107 107
Insufficient Information 83 87
Use of Device Problem 80 80
Thermal Decomposition of Device 78 78
No Audible Alarm 71 71
No Flow 54 54
Temperature Problem 49 49
Explosion 49 49
Melted 42 42
Noise, Audible 38 38
Electrical /Electronic Property Problem 38 38
Unexpected Shutdown 36 36
Smoking 34 34
Insufficient Flow or Under Infusion 30 30
Material Deformation 29 29
Battery Problem 28 28
Improper or Incorrect Procedure or Method 27 27
Excessive Heating 27 27
Contamination 26 26
Device Emits Odor 26 26
Power Problem 25 25
Gas Output Problem 24 24
Infusion or Flow Problem 23 23
Failure to Deliver 22 22
Output Problem 22 22
No Apparent Adverse Event 21 21
Mechanical Problem 21 21
Crack 20 20
Device Alarm System 20 20
Particulates 19 19
Failure to Power Up 19 19
Degraded 18 18
Improper Flow or Infusion 17 17
Sparking 15 15
Gas/Air Leak 14 14
Device Contamination with Chemical or Other Material 12 12
Appropriate Term/Code Not Available 12 12
Failure to Charge 12 12
Material Integrity Problem 11 11
Defective Alarm 10 10
Electrical Shorting 10 10
Therapeutic or Diagnostic Output Failure 10 10
Disconnection 10 10
Complete Loss of Power 9 9
Break 9 9
Intermittent Loss of Power 9 9
Material Discolored 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 830 834
Low Oxygen Saturation 120 120
Burn(s) 116 116
Insufficient Information 106 106
No Consequences Or Impact To Patient 72 72
Partial thickness (Second Degree) Burn 46 46
Dyspnea 44 44
Unspecified Respiratory Problem 44 44
Death 44 44
Hypoxia 41 41
No Known Impact Or Consequence To Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
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
Dizziness 9 9
Skin Inflammation/ Irritation 9 9
Aspiration/Inhalation 9 9
Patient Problem/Medical Problem 9 9
Hypersensitivity/Allergic reaction 8 8
Pain 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
Sleep Dysfunction 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Cognitive Changes 4 4
Respiratory Insufficiency 4 4
Itching Sensation 3 3
Cough 3 3
Confusion/ Disorientation 3 3
Increased Sensitivity 3 3
Epistaxis 3 3
Respiratory Arrest 3 3
Loss of consciousness 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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