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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
CONTEC MEDICAL SYSTEM 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
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
2019 120 120
2020 125 125
2021 194 194
2022 305 305
2023 357 361
2024 132 132

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 116 116
Overheating of Device 112 112
Low Readings 107 107
Adverse Event Without Identified Device or Use Problem 102 102
No Audible Alarm 71 71
Use of Device Problem 64 64
Thermal Decomposition of Device 53 53
Explosion 49 49
Insufficient Information 46 50
Melted 40 40
Noise, Audible 35 35
Unexpected Shutdown 33 33
Temperature Problem 30 30
Material Deformation 29 29
Smoking 29 29
Electrical /Electronic Property Problem 29 29
Insufficient Flow or Under Infusion 28 28
Improper or Incorrect Procedure or Method 22 22
Device Emits Odor 21 21
Gas Output Problem 21 21
Device Alarm System 20 20
Output Problem 20 20
Infusion or Flow Problem 19 19
Contamination 19 19
Particulates 18 18
Crack 17 17
Improper Flow or Infusion 17 17
Power Problem 17 17
No Flow 16 16
Mechanical Problem 16 16
Excessive Heating 14 14
Sparking 14 14
Battery Problem 13 13
No Apparent Adverse Event 13 13
Appropriate Term/Code Not Available 12 12
Gas/Air Leak 12 12
Failure to Power Up 12 12
Device Contamination with Chemical or Other Material 11 11
Material Integrity Problem 11 11
Therapeutic or Diagnostic Output Failure 10 10
Failure to Deliver 10 10
Degraded 10 10
Defective Alarm 10 10
Disconnection 10 10
Break 9 9
Electrical Shorting 9 9
Intermittent Loss of Power 9 9
Failure to Charge 8 8
Defective Component 8 8
Complete Loss of Power 7 7
Detachment of Device or Device Component 6 6
Fracture 6 6
Circuit Failure 5 5
Material Discolored 5 5
Material Rupture 5 5
Product Quality Problem 4 4
Shipping Damage or Problem 4 4
No Audible Prompt/Feedback 4 4
Inaccurate Flow Rate 4 4
Material Disintegration 4 4
Defective Device 4 4
Flare or Flash 4 4
Patient Device Interaction Problem 4 4
Charging Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Fragmentation 3 3
Leak/Splash 3 3
Inaccurate Delivery 3 3
Off-Label Use 3 3
Loss of Power 2 2
Energy Output Problem 2 2
No Device Output 2 2
Tear, Rip or Hole in Device Packaging 2 2
Component Missing 2 2
Vibration 2 2
Loose or Intermittent Connection 2 2
Fluid/Blood Leak 2 2
Corroded 2 2
Burst Container or Vessel 2 2
Protective Measures Problem 2 2
Output below Specifications 2 2
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Device Unsafe to Use in Environment 2 2
Patient-Device Incompatibility 2 2
Human-Device Interface Problem 2 2
No Visual Prompts/Feedback 2 2
Lack of Effect 2 2
Powder Leak 2 2
Intermittent Energy Output 1 1
Unintended Electrical Shock 1 1
Unintended Application Program Shut Down 1 1
Separation Problem 1 1
Unclear Information 1 1
Migration 1 1
Material Split, Cut or Torn 1 1
Free or Unrestricted Flow 1 1
Environmental Particulates 1 1
Filtration Problem 1 1
Ambient Noise Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 660 664
Low Oxygen Saturation 108 108
Burn(s) 87 87
No Consequences Or Impact To Patient 72 72
Insufficient Information 63 63
Death 44 44
Partial thickness (Second Degree) Burn 32 32
No Known Impact Or Consequence To Patient 24 24
Dyspnea 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
No Patient Involvement 16 16
Superficial (First Degree) Burn 14 14
Full thickness (Third Degree) Burn 12 12
Pneumonia 10 10
Patient Problem/Medical Problem 9 9
Headache 8 8
Aspiration/Inhalation 7 7
Pain 6 6
Hypoxia 6 6
No Information 6 6
Unspecified Respiratory Problem 6 6
Swelling/ Edema 6 6
Cognitive Changes 4 4
Burning Sensation 4 4
Dizziness 4 4
Muscle Weakness 4 4
Fall 4 4
Respiratory Distress 3 3
Cyanosis 3 3
Emotional Changes 3 3
Erythema 3 3
Viral Infection 3 3
Arthralgia 3 3
Loss of consciousness 3 3
Respiratory Arrest 3 3
Respiratory Insufficiency 3 3
Increased Sensitivity 3 3
Skin Inflammation/ Irritation 3 3
Unspecified Heart Problem 2 2
Cough 2 2
Respiratory Tract Infection 2 2
Sore Throat 2 2
Anxiety 2 2
Injury 2 2
Confusion/ Disorientation 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 2 2
No Code Available 2 2
Burn, Thermal 2 2
Fainting 2 2
Bruise/Contusion 2 2
Pulmonary Edema 2 2
Myocardial Infarction 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Inflammation 2 2
Itching Sensation 2 2
Laceration(s) 2 2
High Blood Pressure/ Hypertension 1 1
Hypoventilation 1 1
Nausea 1 1
Rash 1 1
Urinary Tract Infection 1 1
Pulmonary Dysfunction 1 1
Stroke/CVA 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Pulmonary Embolism 1 1
Abrasion 1 1
Hearing Loss 1 1
Hyperbilirubinemia 1 1
Dehydration 1 1
Syncope/Fainting 1 1
Heart Failure/Congestive Heart Failure 1 1
Eye Burn 1 1
High Oxygen Saturation 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Ischemic Heart Disease 1 1
Discomfort 1 1
Hot Flashes/Flushes 1 1
Concussion 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Reaction 1 1
Malaise 1 1
Depression 1 1
Disability 1 1
Ventilator Dependent 1 1
Epistaxis 1 1
Easy Bruising 1 1
Unspecified Tissue Injury 1 1
Alteration in Body Temperature 1 1
Decreased Appetite 1 1
Dry Mouth 1 1
Blister 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. II May-19-2022
2 Caire, Inc. II Jan-13-2020
3 Caire, Inc. II Oct-30-2019
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
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