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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, digital image storage, radiological
Definition Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Product CodeLMB
Regulation Number 892.2010
Device Class 1

MDR Year MDR Reports MDR Events
2018 5 5
2019 10 10
2020 8 8
2021 10 10
2023 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 14 14
No Display/Image 10 10
Break 2 2
Poor Quality Image 2 2
No Device Output 2 2
Overheating of Device 2 2
Defective Device 2 2
Operating System Becomes Nonfunctional 1 1
Output below Specifications 1 1
Output Problem 1 1
Power Problem 1 1
Reset Problem 1 1
Noise, Audible 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Loss of Power 1 1
Smoking 1 1
Computer Software Problem 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Application Program Problem: Dose Calculation Error 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Known Impact Or Consequence To Patient 15 15
No Consequences Or Impact To Patient 4 4

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