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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
Product CodeGKN
Regulation Number 864.5400
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 12 12
2022 54 54
2023 120 120
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 175 175
Mechanical Problem 20 20
Device Alarm System 11 11
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Temperature Problem 2 2
No Apparent Adverse Event 2 2
Display or Visual Feedback Problem 2 2
Smoking 1 1
Calibration Problem 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Contamination 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 193 193
Aortic Valve Stenosis 1 1
Stroke/CVA 1 1
Congestive Heart Failure 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1

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