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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
DEVILBISS HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
O2 CONCEPTS LLC
  SUBSTANTIALLY EQUIVALENT 1
OXUS, INC
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.
  SUBSTANTIALLY EQUIVALENT 1
SYSMED (CHINA) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 3167 3167
2017 107 107
2018 116 116
2019 120 120
2020 125 125
2021 148 148

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 2128 2128
No Audible Alarm 414 414
Electrical /Electronic Property Problem 235 235
Fire 169 169
Circuit Failure 165 165
Device Operates Differently Than Expected 150 150
Break 147 147
Adverse Event Without Identified Device or Use Problem 134 134
Electrical Shorting 106 106
Loss of Power 106 106
Defective Alarm 103 103
Defective Device 90 90
Device Displays Incorrect Message 87 87
Device Inoperable 85 85
Overheating of Device 65 65
Melted 47 47
Thermal Decomposition of Device 45 45
Insufficient Information 39 39
Device Operational Issue 37 37
Explosion 35 35
Noise, Audible 31 31
Use of Device Problem 31 31
Improper or Incorrect Procedure or Method 31 31
Defective Component 31 31
Failure to Power Up 26 26
Leak/Splash 25 25
Device Emits Odor 24 24
Smoking 23 23
Out-Of-Box Failure 23 23
No Display/Image 22 22
Mechanical Problem 15 15
Battery Problem 15 15
Infusion or Flow Problem 15 15
Unexpected Shutdown 14 14
Failure to Deliver 13 13
Sparking 11 11
No Flow 10 10
No Apparent Adverse Event 10 10
Light Interference 9 9
Power Problem 9 9
Electronic Property Issue 9 9
Disconnection 9 9
Device Contamination with Chemical or Other Material 8 8
Temperature Problem 8 8
Component Missing 7 7
Environmental Particulates 6 6
Crack 6 6
Gas Output Problem 6 6
Detachment Of Device Component 6 6
Contamination 6 6
No Device Output 6 6
Device Stops Intermittently 6 6
Sticking 5 5
Fluid Leak 5 5
Charging Problem 5 5
Failure to Shut Off 4 4
Therapeutic or Diagnostic Output Failure 4 4
Appropriate Term/Code Not Available 4 4
Output Problem 4 4
Improper Device Output 4 4
Material Discolored 4 4
Insufficient Flow or Under Infusion 4 4
Loose or Intermittent Connection 4 4
Material Frayed 3 3
Failure to Charge 3 3
Improper Flow or Infusion 3 3
Inadequate Lighting 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
No Pressure 3 3
Gas Leak 3 3
Device Damaged Prior to Use 3 3
Environmental Compatibility Problem 3 3
Device Unsafe to Use in Environment 3 3
Computer Operating System Problem 3 3
Patient-Device Incompatibility 3 3
Complete Loss of Power 3 3
Intermittent Loss of Power 2 2
Excessive Heating 2 2
Activation, Positioning or SeparationProblem 2 2
Detachment of Device or Device Component 2 2
Human-Device Interface Problem 2 2
Improper Alarm 2 2
Flare or Flash 2 2
Optical Problem 2 2
Output below Specifications 2 2
Scratched Material 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Material Deformation 2 2
Arcing 2 2
Inadequate User Interface 2 2
Material Disintegration 2 2
Filling Problem 2 2
Unintended Ejection 2 2
Burst Container or Vessel 2 2
Microbial Contamination of Device 2 2
Material Separation 2 2
Device Slipped 2 2
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2980 2980
No Information 169 169
No Consequences Or Impact To Patient 146 146
Death 104 104
No Clinical Signs, Symptoms or Conditions 82 82
Burn(s) 73 73
No Patient Involvement 54 54
Low Oxygen Saturation 53 53
Patient Problem/Medical Problem 25 25
Partial thickness (Second Degree) Burn 23 23
No Code Available 23 23
Insufficient Information 21 21
Respiratory Distress 15 15
Full thickness (Third Degree) Burn 14 14
Dyspnea 10 10
Superficial (First Degree) Burn 9 9
Injury 8 8
Hypoxia 8 8
Burn, Thermal 6 6
Headache 5 5
Pain 5 5
Loss of consciousness 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Complaint, Ill-Defined 3 3
Reaction 3 3
Pneumonia 3 3
Bruise/Contusion 3 3
Dizziness 3 3
Unspecified Infection 3 3
Fainting 3 3
Burning Sensation 2 2
Laceration(s) 2 2
Ventilator Dependent 2 2
Increased Respiratory Rate 2 2
Ischemic Heart Disease 1 1
Shaking/Tremors 1 1
Test Result 1 1
Heart Failure/Congestive Heart Failure 1 1
Epistaxis 1 1
Respiratory Insufficiency 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Sore Throat 1 1
Malaise 1 1
Disability 1 1
Collapse 1 1
Coma 1 1
Respiratory Tract Infection 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
High Oxygen Saturation 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Myocardial Infarction 1 1
Nausea 1 1
Neuropathy 1 1
Seizures 1 1
Sprain 1 1
Vomiting 1 1
Weakness 1 1
Concussion 1 1
Red Eye(s) 1 1
Shock, Traumatic 1 1
Anxiety 1 1
Fall 1 1
Asphyxia 1 1
Hair Loss 1 1
Head Injury 1 1
Inflammation 1 1
Hearing Loss 1 1
High Blood Pressure/ Hypertension 1 1
Pulmonary Emphysema 1 1
Abrasion 1 1
Adult Respiratory Distress Syndrome 1 1
Asthma 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Congestive Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. II Jan-13-2020
2 Caire, Inc. II Oct-30-2019
3 Inovo, Inc II Jan-24-2018
4 Inovo, Inc II Dec-14-2016
5 Invacare Corporation II Dec-01-2020
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