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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 124 124
Adverse Event Without Identified Device or Use Problem 114 114
Fire 112 112
Low Readings 107 107
Use of Device Problem 74 74
Insufficient Information 73 77
Thermal Decomposition of Device 71 71
No Audible Alarm 70 70
Explosion 46 46
Temperature Problem 45 45
Melted 39 39
No Flow 38 38
Electrical /Electronic Property Problem 35 35
Noise, Audible 33 33
Smoking 33 33
Insufficient Flow or Under Infusion 30 30
Unexpected Shutdown 29 29
Material Deformation 28 28
Contamination 25 25
Device Emits Odor 24 24
Battery Problem 24 24
Power Problem 24 24
Improper or Incorrect Procedure or Method 23 23
Excessive Heating 23 23
Output Problem 22 22
Crack 20 20
Gas Output Problem 20 20
Infusion or Flow Problem 20 20
Failure to Deliver 20 20
Particulates 19 19
Mechanical Problem 19 19
Device Alarm System 18 18
Improper Flow or Infusion 17 17
Failure to Power Up 17 17
Degraded 16 16
Sparking 15 15
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
Therapeutic or Diagnostic Output Failure 10 10
Defective Alarm 10 10
No Apparent Adverse Event 10 10
Break 9 9
Complete Loss of Power 9 9
Material Discolored 8 8
Electrical Shorting 8 8
Intermittent Loss of Power 8 8
Defective Component 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 805 809
Low Oxygen Saturation 110 110
Burn(s) 100 100
Insufficient Information 98 98
Unspecified Respiratory Problem 43 43
Dyspnea 42 42
Partial thickness (Second Degree) Burn 39 39
No Consequences Or Impact To Patient 37 37
Hypoxia 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Death 18 18
Full thickness (Third Degree) Burn 17 17
Superficial (First Degree) Burn 14 14
No Known Impact Or Consequence To Patient 12 12
Headache 12 12
No Patient Involvement 11 11
Pneumonia 10 10
Aspiration/Inhalation 9 9
Skin Inflammation/ Irritation 9 9
Swelling/ Edema 8 8
Pain 8 8
Hypersensitivity/Allergic reaction 8 8
Dizziness 8 8
Discomfort 6 6
Unspecified Kidney or Urinary Problem 5 5
Respiratory Tract Infection 5 5
Erythema 5 5
Unspecified Heart Problem 5 5
Muscle Weakness 5 5
No Information 5 5
Distress 5 5
Inflammation 4 4
Cognitive Changes 4 4
Burning Sensation 4 4
Fall 4 4
Viral Infection 4 4
Patient Problem/Medical Problem 3 3
Cough 3 3
Respiratory Insufficiency 3 3
Respiratory Arrest 3 3
Itching Sensation 3 3
Emotional Changes 3 3
Confusion/ Disorientation 3 3
Chronic Obstructive Pulmonary Disease (COPD) 3 3
Respiratory Failure 3 3
Bruise/Contusion 3 3
Arthralgia 3 3
Increased Sensitivity 3 3
Cyanosis 3 3
Unspecified Tissue Injury 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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