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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
2019 7 7
2020 13 13
2021 20 20
2022 18 18
2023 15 15
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 48 48
Application Program Problem 7 7
Smoking 3 3
Application Program Problem: Medication Error 3 3
Excessive Heating 2 2
Data Problem 2 2
Patient Data Problem 2 2
Overheating of Device 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Crack 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
Defective Device 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 5 5
Underdose 2 2
Electric Shock 2 2
Overdose 2 2
Patient Problem/Medical Problem 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Unspecified Tissue Injury 1 1
Skin Irritation 1 1
Torsades-de-Pointes 1 1
Electrolyte Imbalance 1 1
Missed Dose 1 1

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