TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	433	462
Overheating of Device	387	852
Output below Specifications	314	314
Material Puncture/Hole	159	159
No Apparent Adverse Event	148	148
Fluid/Blood Leak	102	569
Noise, Audible	68	68
Difficult to Insert	66	66
Break	57	55
Unintended System Motion	51	51
Vibration	48	48
Material Twisted/Bent	43	43
Leak/Splash	42	272
Physical Resistance/Sticking	42	43
Naturally Worn	40	40
Excessive Heating	36	36
Difficult to Remove	34	34
Complete Loss of Power	33	33
Corroded	30	30
Burst Container or Vessel	29	44
Fracture	29	29
Loss of Power	27	27
Device Remains Activated	26	26
Electrical /Electronic Property Problem	26	26
Appropriate Term/Code Not Available	16	16
Unintended Power Up	15	22
Mechanical Jam	12	12
Material Rupture	11	11
Premature Separation	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Misconnection	8	8
Material Fragmentation	7	7
Fail-Safe Did Not Operate	5	5
Unexpected Shutdown	5	5
Mechanical Problem	5	5
Insufficient Information	5	5
Material Deformation	5	5
Intermittent Loss of Power	4	4
Energy Output Problem	4	4
Gas/Air Leak	4	4
Fail-Safe Problem	4	9
Failure to Auto Stop	3	3
Degraded	3	3
Device-Device Incompatibility	3	3
Device Reprocessing Problem	2	2
Material Integrity Problem	2	2
Smoking	2	2
Structural Problem	1	1
Device Damaged by Another Device	1	1
Failure to Align	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1307	2110
No Consequences Or Impact To Patient	315	541
No Patient Involvement	104	511
No Known Impact Or Consequence To Patient	75	213
Insufficient Information	18	132
Burn(s)	13	13
Chemical Exposure	13	13
Perforation	12	12
Unintended Radiation Exposure	9	9
Injury	9	9
Device Embedded In Tissue or Plaque	8	8
Cerebrospinal Fluid Leakage	6	6
Unspecified Tissue Injury	6	6
Hearing Impairment	6	6
Tissue Damage	5	5
Hemorrhage/Bleeding	5	5
Unspecified Infection	5	5
Spinal Column Injury	4	4
Foreign Body In Patient	4	4
Nerve Damage	4	4
Death	3	3
Tinnitus	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	2	55
Pain	2	2
Spinal Cord Injury	2	2
Muscle Weakness	1	1
Hematoma	1	1
Contusion	1	1
No Code Available	1	1
Intracranial Hemorrhage	1	1
Oversedation	1	1
Radiation Exposure, Unintended	1	1
Failure of Implant	1	1
Numbness	1	1
Awareness during Anaesthesia	1	1
Laceration(s)	1	1
Acoustic Trauma	1	2
Reaction	1	1
Fatigue	1	1
Partial thickness (Second Degree) Burn	1	3
Headache	1	1