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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, signal isolation
Regulation Description Signal isolation system.
Product CodeDRJ
Regulation Number 870.2600
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 3 3
2024 2 2
2025 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 6 6
Output Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Display or Visual Feedback Problem 2 2
Material Frayed 1 1
Difficult to Insert 1 1
Smoking 1 1
Sparking 1 1
Signal Artifact/Noise 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Necrosis 1 1
Cardiac Arrest 1 1
Cardiac Perforation 1 1

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