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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device medical computers and software
Product CodeLNX
Device Class Unclassified

MDR Year MDR Reports MDR Events
2018 10 10
2019 7 7
2020 13 13
2021 20 20
2022 18 18
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 52 52
Application Program Problem 8 8
Smoking 3 3
Data Problem 3 3
Application Program Problem: Medication Error 3 3
Excessive Heating 2 2
Patient Data Problem 2 2
Overheating of Device 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Crack 1 1
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 8 8
Overdose 3 3
Underdose 2 2
Electric Shock 2 2
Patient Problem/Medical Problem 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Tissue Injury 1 1
Death 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Missed Dose 1 1
Skin Irritation 1 1
Torsades-de-Pointes 1 1
Electrolyte Imbalance 1 1

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