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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device changer, tube, endotracheal
Product CodeLNZ
Regulation Number 868.5730
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 4 4
2022 4 4
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 2 2
Break 1 1
Display or Visual Feedback Problem 1 1
Inflation Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Gas/Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 3 3
Cyanosis 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sarnova HC, Llc II Mar-19-2024
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