TPLC - Total Product Life Cycle

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Device	system, digital image communications, radiological
Regulation Description	Medical image communications device.
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
No Display/Image	5	5
Unexpected Shutdown	4	4
Complete Loss of Power	4	4
Display or Visual Feedback Problem	4	4
Output Problem	3	3
Erratic or Intermittent Display	3	3
Fire	2	2
Material Integrity Problem	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
Device Operational Issue	1	1
Application Program Version or Upgrade Problem	1	1
Insufficient Information	1	1
Smoking	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination /Decontamination Problem	1	1
Battery Problem	1	1
Program or Algorithm Execution Problem	1	1
Use of Device Problem	1	1
Power Problem	1	1
Overheating of Device	1	1
Loose or Intermittent Connection	1	1
No Device Output	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27	27
Insufficient Information	7	7
Unspecified Infection	1	1
Radiation Exposure, Unintended	1	1
Bowel Perforation	1	1
Partial thickness (Second Degree) Burn	1	1