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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
2019 10 10
2020 8 8
2021 10 10
2023 10 10
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 14 14
No Display/Image 9 9
Poor Quality Image 2 2
Overheating of Device 2 2
Defective Device 2 2
Communication or Transmission Problem 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
Smoking 1 1
No Device Output 1 1
Application Program Problem: Dose Calculation Error 1 1
Image Display Error/Artifact 1 1
Break 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 3 3

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