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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device timer, clot, automated
Regulation Description Coagulation instrument.
Product CodeGKN
Regulation Number 864.5400
Device Class 2

MDR Year MDR Reports MDR Events
2021 12 12
2022 54 54
2023 120 120
2024 54 54
2025 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 270 270
Mechanical Problem 21 21
Device Alarm System 13 13
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Display or Visual Feedback Problem 3 3
Temperature Problem 3 3
Calibration Problem 2 2
Material Deformation 2 2
No Apparent Adverse Event 2 2
Smoking 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 289 289
Stroke/CVA 1 1
Hemorrhage/Bleeding 1 1

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