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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, liquid-oxygen, portable
Regulation Description Portable liquid oxygen unit.
Product CodeBYJ
Regulation Number 868.5655
Device Class 2

MDR Year MDR Reports MDR Events
2016 19 19
2017 18 18
2018 21 21
2019 24 24
2020 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 51 51
Leak/Splash 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 9 9
Device Operates Differently Than Expected 7 7
Defective Component 6 6
Use of Device Problem 4 4
Appropriate Term/Code Not Available 4 4
Fire 4 4
Infusion or Flow Problem 3 3
No Flow 2 2
Gas Leak 2 2
Break 2 2
Burst Container or Vessel 1 1
Crack 1 1
Device Operational Issue 1 1
Failure to Shut Off 1 1
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1
Improper Flow or Infusion 1 1
Chemical Spillage 1 1
Material Integrity Problem 1 1
Valve(s) 1 1
Inaccurate Flow Rate 1 1
Moisture Damage 1 1
Sticking 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 35 35
Burn(s) 25 25
Burn, Thermal 24 24
Death 7 7
No Known Impact Or Consequence To Patient 6 6
Low Oxygen Saturation 4 4
Chronic Obstructive Pulmonary Disease (COPD) 4 4
No Code Available 4 4
No Patient Involvement 3 3
Partial thickness (Second Degree) Burn 3 3
Cryogenic Burn 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Pulmonary Emphysema 2 2
Hyperglycemia 2 2
Hypoxia 2 2
Respiratory Distress 1 1
Hemorrhage/Bleeding 1 1
Distress 1 1
Discomfort 1 1
Chemical Exposure 1 1
Full thickness (Third Degree) Burn 1 1
Atrial Fibrillation 1 1
Fatigue 1 1
Pulmonary Embolism 1 1
Abrasion 1 1

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