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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device densitometer/scanner (integrating, reflectance, tlc, radiochromat.) clinica
Regulation Description Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
Product CodeJQT
Regulation Number 862.2400
Device Class 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 5 5
2023 6 6
2024 4 4
2025 5 5
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 15 15
Smoking 7 7
Electrical /Electronic Property Problem 6 6
Unintended Electrical Shock 5 5
Noise, Audible 5 5
Fail-Safe Problem 2 2
Failure of Device to Self-Test 2 2
Unexpected Shutdown 1 1
Fire 1 1
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Failure to Power Up 1 1
Power Problem 1 1
Overheating of Device 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
Electric Shock 1 1
Insufficient Information 1 1

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