TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	102	692
Intermittent Loss of Power	96	417
Electrical /Electronic Property Problem	92	340
Mechanical Jam	71	188
Grounding Malfunction	61	198
Mechanical Problem	45	63
Fluid/Blood Leak	43	255
Sharp Edges	22	33
Positioning Failure	19	21
Device Slipped	15	20
Device Fell	10	10
Break	7	7
Insufficient Information	7	7
Patient Device Interaction Problem	5	5
Collapse	3	3
Unintended Movement	3	3
Defective Component	3	3
Fire	2	2
Unintended Electrical Shock	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Leak/Splash	1	1
Output Problem	1	1
Smoking	1	1
Material Integrity Problem	1	1
No Audible Alarm	1	1
Battery Problem	1	1
Component Missing	1	1
Incorrect Measurement	1	2
Device Displays Incorrect Message	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	537	2191
Insufficient Information	80	105
Pain	15	48
Muscle/Tendon Damage	10	34
Fall	7	12
Electric Shock	5	14
Laceration(s)	5	5
Exposure to Body Fluids	2	2
Bruise/Contusion	2	14
Joint Dislocation	1	1
Fatigue	1	1
Unspecified Musculoskeletal problem	1	4
Bone Fracture(s)	1	1
Concussion	1	1
Shock	1	1
Convulsion/Seizure	1	1