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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
Regulation Description Medical image storage device.
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
2020 8 8
2021 10 10
2023 10 10
2024 9 9
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 14 14
No Display/Image 6 6
Loss of Power 2 2
Computer Software Problem 2 2
Image Display Error/Artifact 2 2
Poor Quality Image 2 2
Noise, Audible 1 1
Communication or Transmission Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Loss of Data 1 1
No Device Output 1 1
Power Problem 1 1
Output below Specifications 1 1
Smoking 1 1
Output Problem 1 1
Defective Device 1 1
Overheating of Device 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2

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