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
Device Operational Issue	6	6
No Display/Image	3	3
Complete Loss of Power	3	3
Unexpected Shutdown	2	2
Fire	2	2
Smoking	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
Erratic or Intermittent Display	2	2
Contamination /Decontamination Problem	1	1
Program or Algorithm Execution Problem	1	1
Use of Device Problem	1	1
Data Problem	1	1
Device Emits Odor	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14	14
Radiation Exposure, Unintended	6	6
Insufficient Information	3	3
No Known Impact Or Consequence To Patient	2	2
Unspecified Infection	1	1
No Code Available	1	1
Bowel Perforation	1	1
Partial thickness (Second Degree) Burn	1	1