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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
2019 24 24
2020 39 39
2021 7 7
2022 4 4
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 47 47
Use of Device Problem 8 8
Fire 8 8
Leak/Splash 7 7
Defective Component 6 6
Insufficient Information 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Detachment of Device or Device Component 2 2
Infusion or Flow Problem 2 2
Material Integrity Problem 1 1
Gas/Air Leak 1 1
No Pressure 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Problem 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 21 21
Burn(s) 17 17
Burn, Thermal 16 16
Cryogenic Burn 12 12
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 4 4
No Known Impact Or Consequence To Patient 4 4
Full thickness (Third Degree) Burn 3 3
Death 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 1 1
Partial thickness (Second Degree) Burn 1 1
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
Hypoxia 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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