TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Nonstandard Device	72	72
Device Sensing Problem	30	30
Incorrect, Inadequate or Imprecise Resultor Readings	29	29
Failure to Sense	27	27
False Negative Result	26	26
Low Test Results	17	17
Battery Problem	13	13
Complete Loss of Power	9	9
Electrical /Electronic Property Problem	9	9
Failure to Run on Battery	6	6
Temperature Problem	5	5
Device Handling Problem	5	5
Noise, Audible	5	5
Material Integrity Problem	4	4
Electrical Overstress	4	4
Failure to Power Up	4	4
Overheating of Device	4	4
Corroded	4	4
Degraded	4	4
Bent	3	3
Calibration Problem	3	3
Electrical Shorting	3	3
Improper or Incorrect Procedure or Method	2	2
Imprecision	2	2
Leak/Splash	2	2
Smoking	2	2
Use of Device Problem	1	1
Product Quality Problem	1	1
Moisture Damage	1	1
False Positive Result	1	1
Fluid Leak	1	1
Power Problem	1	1
Improper Chemical Reaction	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Electrical Power Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	94	94
Insufficient Information	50	50
No Consequences Or Impact To Patient	26	26
No Clinical Signs, Symptoms or Conditions	23	23
No Patient Involvement	9	9
Test Result	9	9
Patient Problem/Medical Problem	6	6
No Information	5	5
Burn(s)	1	1
Superficial (First Degree) Burn	1	1
Burn, Thermal	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1