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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
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 2
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
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
Overheating of Device 125 125
Adverse Event Without Identified Device or Use Problem 119 119
Fire 114 114
Low Readings 107 107
Insufficient Information 78 82
Use of Device Problem 76 76
Thermal Decomposition of Device 73 73
No Audible Alarm 70 70
Temperature Problem 48 48
Explosion 46 46
No Flow 42 42
Melted 39 39
Electrical /Electronic Property Problem 37 37
Smoking 33 33
Noise, Audible 33 33
Unexpected Shutdown 30 30
Insufficient Flow or Under Infusion 30 30
Material Deformation 28 28
Battery Problem 25 25
Excessive Heating 25 25
Power Problem 25 25
Contamination 25 25
Device Emits Odor 24 24
Improper or Incorrect Procedure or Method 23 23
Output Problem 22 22
Gas Output Problem 21 21
Infusion or Flow Problem 20 20
Crack 20 20
Failure to Deliver 20 20
Particulates 19 19
Mechanical Problem 19 19
Failure to Power Up 18 18
Device Alarm System 18 18
Degraded 18 18
Improper Flow or Infusion 17 17
Sparking 15 15
No Apparent Adverse Event 14 14
Gas/Air Leak 13 13
Failure to Charge 12 12
Appropriate Term/Code Not Available 12 12
Material Integrity Problem 11 11
Device Contamination with Chemical or Other Material 11 11
Defective Alarm 10 10
Therapeutic or Diagnostic Output Failure 10 10
Complete Loss of Power 9 9
Break 9 9
Intermittent Loss of Power 8 8
Electrical Shorting 8 8
Material Discolored 8 8
Circuit Failure 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 822 826
Low Oxygen Saturation 111 111
Burn(s) 102 102
Insufficient Information 101 101
Unspecified Respiratory Problem 43 43
Dyspnea 42 42
Partial thickness (Second Degree) Burn 42 42
No Consequences Or Impact To Patient 37 37
Hypoxia 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Death 18 18
Full thickness (Third Degree) Burn 17 17
Superficial (First Degree) Burn 14 14
Headache 12 12
No Known Impact Or Consequence To Patient 12 12
No Patient Involvement 11 11
Pneumonia 10 10
Aspiration/Inhalation 9 9
Skin Inflammation/ Irritation 9 9
Pain 8 8
Hypersensitivity/Allergic reaction 8 8
Dizziness 8 8
Swelling/ Edema 8 8
Distress 6 6
Discomfort 6 6
Erythema 5 5
Respiratory Tract Infection 5 5
No Information 5 5
Unspecified Heart Problem 5 5
Muscle Weakness 5 5
Unspecified Kidney or Urinary Problem 5 5
Viral Infection 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
Burning Sensation 4 4
Inflammation 4 4
Cognitive Changes 4 4
Fall 4 4
Respiratory Insufficiency 4 4
Arthralgia 3 3
Patient Problem/Medical Problem 3 3
Respiratory Failure 3 3
Increased Sensitivity 3 3
Cough 3 3
Confusion/ Disorientation 3 3
Respiratory Arrest 3 3
Emotional Changes 3 3
Bruise/Contusion 3 3
Cyanosis 3 3
Itching Sensation 3 3
Decreased Appetite 2 2

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 DeVilbiss Healthcare LLC II May-04-2023
5 DeVilbiss Healthcare LLC II Dec-19-2022
6 DeVilbiss Healthcare LLC II Nov-11-2022
7 Invacare Corporation III Jul-12-2022
8 Invacare Corporation II Dec-01-2020
9 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD I Jan-03-2025
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