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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
Product CodeDRJ
Regulation Number 870.2600
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 7 7
2021 3 3
2022 4 4
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 9 9
Output Problem 3 3
Display or Visual Feedback Problem 2 2
Smoking 2 2
Signal Artifact/Noise 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Power Problem 1 1
Detachment of Device or Device Component 1 1
Mechanical Problem 1 1
Tactile Prompts/Feedback 1 1
Erratic or Intermittent Display 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 10 10
No Patient Involvement 1 1
Necrosis 1 1

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