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
Display or Visual Feedback Problem	9	9
No Display/Image	8	8
Erratic or Intermittent Display	4	4
Output Problem	4	4
Complete Loss of Power	4	4
Unexpected Shutdown	4	4
No Apparent Adverse Event	3	3
Unintended Application Program Shut Down	2	2
Material Integrity Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Fire	2	2
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
No Device Output	1	1
Overheating of Device	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Smoking	1	1
Use of Device Problem	1	2
Sparking	1	1
Application Program Version or Upgrade Problem	1	1
Battery Problem	1	1
Communication or Transmission Problem	1	1
Device-Device Incompatibility	1	1
Optical Problem	1	1
Power Problem	1	1
Temperature Problem	1	1
Electrical /Electronic Property Problem	1	1
Program or Algorithm Execution Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	42	43
Insufficient Information	8	8
Bowel Perforation	1	1
Partial thickness (Second Degree) Burn	1	1