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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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 14 14
No Display/Image 11 11
Image Display Error/Artifact 2 2
Poor Quality Image 2 2
Defective Device 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Overheating of Device 2 2
Loss of Power 2 2
No Device Output 2 2
Reset Problem 1 1
Unexpected Shutdown 1 1
Break 1 1
Communication or Transmission Problem 1 1
Output Problem 1 1
Smoking 1 1
Application Program Problem: Dose Calculation Error 1 1
Computer Software Problem 1 1
Power Problem 1 1
Loss of Data 1 1
Output below Specifications 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 3 3

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