TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Output below Specifications	314	314
Overheating of Device	257	681
Detachment of Device or Device Component	243	270
Material Puncture/Hole	159	159
No Apparent Adverse Event	114	114
Fluid/Blood Leak	96	533
Noise, Audible	59	59
Break	56	54
Unintended System Motion	48	48
Leak/Splash	42	272
Material Twisted/Bent	41	41
Vibration	38	38
Excessive Heating	36	36
Complete Loss of Power	32	32
Physical Resistance/Sticking	30	31
Difficult to Insert	28	28
Burst Container or Vessel	28	42
Device Remains Activated	26	26
Fracture	26	26
Difficult to Remove	23	23
Electrical /Electronic Property Problem	21	21
Naturally Worn	20	20
Unintended Power Up	15	22
Appropriate Term/Code Not Available	14	14
Mechanical Jam	12	12
Material Rupture	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Premature Separation	8	8
Loss of Power	7	7
Misconnection	7	7
Material Fragmentation	7	7
Unexpected Shutdown	5	5
Mechanical Problem	5	5
Insufficient Information	5	5
Intermittent Loss of Power	4	4
Energy Output Problem	4	4
Fail-Safe Problem	4	9
Gas/Air Leak	4	4
Failure to Auto Stop	3	3
Device-Device Incompatibility	3	3
Degraded	3	3
Fail-Safe Did Not Operate	3	3
Material Deformation	2	2
Smoking	2	2
Corroded	1	1
Intermittent Energy Output	1	1
Loose or Intermittent Connection	1	1
Device Reprocessing Problem	1	1
Unintended Movement	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	922	1651
No Consequences Or Impact To Patient	315	541
No Patient Involvement	104	511
No Known Impact Or Consequence To Patient	75	213
Insufficient Information	17	100
Chemical Exposure	13	13
Perforation	12	12
Burn(s)	11	11
Unintended Radiation Exposure	9	9
Injury	9	9
Device Embedded In Tissue or Plaque	7	7
Hearing Impairment	6	6
Cerebrospinal Fluid Leakage	6	6
Unspecified Tissue Injury	6	6
Unspecified Infection	5	5
Hemorrhage/Bleeding	5	5
Tissue Damage	5	5
Spinal Column Injury	4	4
Foreign Body In Patient	4	4
Nerve Damage	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Death	3	3
Tinnitus	3	3
Spinal Cord Injury	2	2
No Information	2	55
Pain	2	2
Headache	1	1
Partial thickness (Second Degree) Burn	1	3
Reaction	1	1
Acoustic Trauma	1	2
Awareness during Anaesthesia	1	1
Laceration(s)	1	1
Numbness	1	1
Intracranial Hemorrhage	1	1
Oversedation	1	1
Contusion	1	1
Muscle Weakness	1	1
Hematoma	1	1
No Code Available	1	1
Fatigue	1	1
Radiation Exposure, Unintended	1	1
Failure of Implant	1	1