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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
2019 4 4
2020 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 3 3
Output Problem 2 2
Display or Visual Feedback Problem 1 1
Mechanical Problem 1 1
Smoking 1 1
Erratic or Intermittent Display 1 1
Power Problem 1 1
Tactile Prompts/Feedback 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
No Patient Involvement 1 1

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