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	362	362
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
Appropriate Term/Code Not Available	9	9
Device Fell	9	9
Sparking	8	8
False Negative Result	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
Device Ingredient or Reagent Problem	3	3
Contamination /Decontamination Problem	2	2
Calibration Problem	2	2
Device Emits Odor	2	2
Insufficient Information	2	2
No Apparent Adverse Event	2	2
Fracture	2	2
Unintended Power Up	2	2
Overheating of Device	2	2
Intermittent Program or Algorithm Execution	2	2
Electrical /Electronic Property Problem	2	2
False Positive Result	2	2
Unable to Obtain Readings	1	1
Program or Algorithm Execution Problem	1	1
Degraded	1	1
Obstruction of Flow	1	1
Failure to Align	1	1
Material Twisted/Bent	1	1
Patient Data Problem	1	1
Mechanics Altered	1	1
Material Integrity Problem	1	1
Audible Prompt/Feedback Problem	1	1
Data Problem	1	1
Device Handling Problem	1	1
Program or Algorithm Execution Failure	1	1
Labelling, Instructions for Use or Training Problem	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	732	732
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
Discomfort	1	1
Pain	1	1
Limb Fracture	1	1
Swelling/ Edema	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1