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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
Product CodeBYJ
Regulation Number 868.5655
Device Class 2

MDR Year MDR Reports MDR Events
2018 21 21
2019 24 24
2020 39 39
2021 7 7
2022 4 4
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 53 53
Fire 10 10
Leak/Splash 9 9
Defective Component 6 6
Use of Device Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 4 4
Infusion or Flow Problem 3 3
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Gas/Air Leak 1 1
Material Integrity Problem 1 1
No Pressure 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 1 1
Break 1 1
Burst Container or Vessel 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 31 31
Burn, Thermal 24 24
Burn(s) 14 14
Cryogenic Burn 10 10
Insufficient Information 5 5
Death 5 5
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 1 1
No Code Available 1 1
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
Hypoxia 1 1
Respiratory Distress 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Low Oxygen Saturation 1 1
Pulmonary Embolism 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. I Dec-02-2022
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