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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
2015 3 3
2017 2 2
2019 1 1
2020 1 1
2021 12 12
2022 54 54
2023 120 120
2024 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 207 207
Mechanical Problem 20 20
Device Alarm System 11 11
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Insufficient Information 3 3
Material Deformation 3 3
Display or Visual Feedback Problem 3 3
Temperature Problem 3 3
No Apparent Adverse Event 2 2
Contamination 1 1
Incorrect Measurement 1 1
Device Operates Differently Than Expected 1 1
Smoking 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 225 225
Stroke/CVA 3 3
Aortic Valve Stenosis 3 3
Congestive Heart Failure 2 2
Hemorrhage/Bleeding 2 2
Non specific EKG/ECG Changes 1 1
Death 1 1
Aortic Insufficiency 1 1
Transient Ischemic Attack 1 1
Intracranial Hemorrhage 1 1
Hemorrhage, Cerebral 1 1
Calcium Deposits/Calcification 1 1
Myocardial Infarction 1 1
Corneal Pannus 1 1
Thrombus 1 1

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