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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
Defective Device 2 2
Overheating of Device 2 2
Poor Quality Image 2 2
Reset Problem 1 1
Image Display Error/Artifact 1 1
Unexpected Shutdown 1 1
Break 1 1
Noise, Audible 1 1
No Device Output 1 1
Output Problem 1 1
Computer Software Problem 1 1
Smoking 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Output below Specifications 1 1
Application Program Problem: Dose Calculation Error 1 1
Power Problem 1 1
Communication or Transmission 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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