TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	1150	1150
Power Problem	408	408
Unstable	365	365
Patient Device Interaction Problem	287	287
Intermittent Loss of Power	252	252
Gas/Air Leak	241	241
Appropriate Term/Code Not Available	225	225
Material Frayed	160	160
Calibration Problem	143	143
Mechanical Problem	109	109
Component Missing	98	98
Failure to Power Up	96	96
Noise, Audible	94	94
Incorrect, Inadequate or Imprecise Result or Readings	81	81
Material Deformation	80	80
Loss of Power	69	69
Naturally Worn	67	67
Output Problem	63	63
Corroded	57	57
Break	57	57
Insufficient Information	55	55
Physical Resistance/Sticking	53	53
Loose or Intermittent Connection	52	52
Fitting Problem	48	48
Electrical /Electronic Property Problem	42	42
Adverse Event Without Identified Device or Use Problem	34	34
Incorrect Measurement	32	32
Output below Specifications	30	30
Positioning Problem	24	24
Material Integrity Problem	24	24
Structural Problem	22	22
Material Twisted/Bent	21	21
Vibration	20	20
Material Split, Cut or Torn	20	20
Detachment of Device or Device Component	15	15
Electrical Power Problem	14	14
Pressure Problem	14	14
Activation Problem	13	13
Dull, Blunt	13	13
Unexpected Shutdown	12	12
Overheating of Device	12	12
Connection Problem	10	10
Failure to Disconnect	8	8
Fluid/Blood Leak	8	8
Failure to Calibrate	7	7
Degraded	7	7
Misassembled	6	6
Mechanical Jam	6	6
Complete Loss of Power	6	6
Excessive Heating	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2101	2101
No Patient Involvement	332	332
No Consequences Or Impact To Patient	263	263
Laceration(s)	256	256
No Known Impact Or Consequence To Patient	219	219
Abrasion	175	175
Insufficient Information	71	71
Unspecified Tissue Injury	50	50
No Code Available	42	42
Injury	15	15
Scar Tissue	15	15
Localized Skin Lesion	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Physical Asymmetry	6	6
Skin Tears	5	5
Muscle/Tendon Damage	4	4
Impaired Healing	3	3
No Information	3	3
Suture Abrasion	3	3
Burn(s)	3	3
Patient Problem/Medical Problem	2	2
Failure of Implant	2	2
Scarring	2	2
Tissue Damage	2	2
Tissue Breakdown	2	2
Superficial (First Degree) Burn	1	1
Hematoma	1	1
Adhesion(s)	1	1
Crushing Injury	1	1
Pain	1	1
Hair Loss	1	1
Sedation	1	1
Wrinkling	1	1
Partial thickness (Second Degree) Burn	1	1
Full thickness (Third Degree) Burn	1	1