TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	363	363
Mechanical Problem	326	326
Break	137	137
Structural Problem	130	130
Fluid/Blood Leak	92	92
Leak/Splash	34	34
Air/Gas in Device	18	18
Fire	10	10
Circuit Failure	9	9
False Negative Result	9	9
Appropriate Term/Code Not Available	9	9
Device Fell	9	9
Sparking	8	8
Off-Label Use	7	7
Excessive Heating	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Use of Device Problem	7	7
Device Remains Activated	5	5
Detachment of Device or Device Component	4	4
Smoking	4	4
Thermal Decomposition of Device	4	4
Improper or Incorrect Procedure or Method	3	3
Unexpected Color	3	3
Program or Algorithm Execution Problem	3	3
Device Ingredient or Reagent Problem	3	3
Contamination /Decontamination Problem	2	2
False Positive Result	2	2
Electrical /Electronic Property Problem	2	2
Intermittent Program or Algorithm Execution	2	2
Overheating of Device	2	2
Program or Algorithm Execution Failure	2	2
Calibration Problem	2	2
Unintended Power Up	2	2
Insufficient Information	2	2
Device Emits Odor	2	2
Fracture	2	2
No Apparent Adverse Event	2	2
Temperature Problem	1	1
Low Test Results	1	1
Fumes or Vapors	1	1
Display or Visual Feedback Problem	1	1
Naturally Worn	1	1
Connection Problem	1	1
Output Problem	1	1
Protective Measures Problem	1	1
Power Problem	1	1
Computer Software Problem	1	1
Electrical Shorting	1	1
Device Sensing Problem	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	739	739
Insufficient Information	19	19
Blister	2	2
Fall	2	2
Laceration(s)	2	2
Partial thickness (Second Degree) Burn	2	2
No Consequences Or Impact To Patient	2	2
Bruise/Contusion	2	2
Corneal Clouding/Hazing	1	1
Electric Shock	1	1
Fungal Infection	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Nerve Damage	1	1
Discomfort	1	1
Pain	1	1
Limb Fracture	1	1
Swelling/ Edema	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1