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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
2021 7 7
2022 4 4
2023 10 10
2024 10 10
2025 1 1
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 10 10
Fluid/Blood Leak 7 7
Fire 6 6
Use of Device Problem 5 5
Insufficient Information 4 4
Mechanical Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Device 1 1
No Pressure 1 1
Gas/Air Leak 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
No Flow 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cryogenic Burn 17 17
Insufficient Information 6 6
Burn(s) 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Full thickness (Third Degree) Burn 2 2
Hypoxia 1 1
Respiratory Insufficiency 1 1

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