TPLC - Total Product Life Cycle

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Device	system, digital image communications, radiological
Definition	A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.
Product Code	LMD
Regulation Number	892.2020
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unexpected Shutdown	4	4
No Display/Image	3	3
Device Operational Issue	3	3
Erratic or Intermittent Display	3	3
Complete Loss of Power	3	3
Fire	2	2
Unintended Application Program Shut Down	2	2
Adverse Event Without Identified Device or Use Problem	2	2
No Apparent Adverse Event	2	2
Smoking	1	1
Contamination /Decontamination Problem	1	1
Program or Algorithm Execution Problem	1	1
Use of Device Problem	1	1
Overheating of Device	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
Radiation Exposure, Unintended	3	3
Insufficient Information	3	3
Unspecified Infection	1	1
Bowel Perforation	1	1
Partial thickness (Second Degree) Burn	1	1