TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2694	2694
Mechanical Jam	1725	1725
Mechanical Problem	445	445
Protective Measures Problem	358	358
Insufficient Information	199	199
Noise, Audible	157	157
Flaked	148	148
Break	102	102
No Apparent Adverse Event	70	70
Material Fragmentation	68	68
Electrical Shorting	64	64
Communication or Transmission Problem	58	58
Physical Resistance/Sticking	53	53
Material Separation	39	39
Detachment of Device or Device Component	32	32
Electrical /Electronic Property Problem	31	31
Activation Failure	30	30
Connection Problem	28	28
Failure to Power Up	28	28
Unintended Power Up	28	28
Self-Activation or Keying	27	27
Corroded	27	27
Adverse Event Without Identified Device or Use Problem	26	26
Key or Button Unresponsive/not Working	26	26
Material Deformation	24	24
Temperature Problem	23	23
Smoking	22	22
Unexpected Shutdown	18	18
Activation Problem	18	18
Appropriate Term/Code Not Available	15	15
Device Displays Incorrect Message	15	15
Intermittent Energy Output	11	11
Device Markings/Labelling Problem	11	11
Melted	10	10
Material Twisted/Bent	10	10
Material Integrity Problem	9	9
Therapeutic or Diagnostic Output Failure	9	9
Output below Specifications	9	9
Dull, Blunt	8	8
Failure to Shut Off	8	8
Output Problem	8	8
Circuit Failure	7	7
Fluid/Blood Leak	7	7
Defective Component	7	7
Device Emits Odor	7	7
Power Problem	7	7
Loss of Power	6	6
Unintended Movement	6	6
Fracture	6	6
Material Frayed	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3594	3594
No Patient Involvement	852	852
No Known Impact Or Consequence To Patient	813	813
No Information	170	170
Foreign Body In Patient	44	44
No Consequences Or Impact To Patient	36	36
Insufficient Information	30	30
Burn(s)	16	16
Injury	10	10
Partial thickness (Second Degree) Burn	4	4
Unspecified Infection	3	3
Loss of Range of Motion	3	3
Pain	3	3
Device Embedded In Tissue or Plaque	3	3
Patient Problem/Medical Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Code Available	2	2
Burn, Thermal	2	2
Capsular Contracture	2	2
Hemorrhage/Bleeding	2	2
Metal Related Pathology	1	1
Unspecified Musculoskeletal problem	1	1
Adhesion(s)	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Inflammation	1	1
Muscle Weakness	1	1
Rupture	1	1
Blister	1	1
Post Operative Wound Infection	1	1
Intracranial Hemorrhage	1	1
Laceration(s)	1	1
Scar Tissue	1	1
Eye Injury	1	1
Forced Expiratory Volume Decreased	1	1
Unspecified Tissue Injury	1	1
Fibrosis	1	1
Full thickness (Third Degree) Burn	1	1