TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	52	52
Fluid/Blood Leak	29	29
Mechanical Problem	9	9
Device Maintenance Issue	5	5
Insufficient Information	4	4
Device Operates Differently Than Expected	4	4
Positioning Failure	4	4
Loose or Intermittent Connection	4	4
Unintended System Motion	4	4
Device Slipped	4	4
Break	3	3
Mechanics Altered	3	3
Positioning Problem	3	3
Use of Device Problem	2	2
Detachment Of Device Component	2	2
Difficult or Delayed Positioning	2	2
Leak/Splash	1	1
Collapse	1	1
Unintended Arm Motion	1	1
Signal Artifact/Noise	1	1
Device Stops Intermittently	1	1
Device Inoperable	1	1
Decrease in Pressure	1	1
Migration or Expulsion of Device	1	1
Misconnection	1	1
Solder Joint Fracture	1	1
Device Displays Incorrect Message	1	1
Patient-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Sensing Problem	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	68	68
No Known Impact Or Consequence To Patient	22	22
No Patient Involvement	19	19
No Consequences Or Impact To Patient	5	5
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Injury	2	2
Hemorrhage/Bleeding	2	2
Laceration(s)	2	2
Pain	2	2
Fall	2	2
Head Injury	1	1
Bruise/Contusion	1	1
Cerebrospinal Fluid Leakage	1	1
Not Applicable	1	1
No Information	1	1
No Code Available	1	1
Muscle/Tendon Damage	1	1