TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	73	73
Device Slipped	36	36
Mechanical Problem	28	28
Adverse Event Without Identified Device or Use Problem	26	26
Material Split, Cut or Torn	15	15
Insufficient Information	10	10
Patient Device Interaction Problem	7	7
Defective Device	7	7
Positioning Problem	5	5
Material Integrity Problem	5	5
Material Frayed	5	5
Defective Component	5	5
Product Quality Problem	5	5
Material Disintegration	4	4
Labelling, Instructions for Use or Training Problem	4	4
Misassembled	4	4
Detachment of Device or Device Component	4	4
Fail-Safe Problem	3	3
Human-Device Interface Problem	3	3
Connection Problem	3	3
Activation, Positioning or Separation Problem	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	2	2
Appropriate Term/Code Not Available	2	2
Difficult or Delayed Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Material Separation	1	1
Structural Problem	1	1
Use of Device Problem	1	1
Off-Label Use	1	1
Crack	1	1
Disconnection	1	1
Inadequate Instructions for Healthcare Professional	1	1
Loose or Intermittent Connection	1	1
Material Too Soft/Flexible	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	123	123
No Consequences Or Impact To Patient	51	51
Extubate	21	21
Insufficient Information	19	19
No Known Impact Or Consequence To Patient	6	6
Irritability	5	5
Skin Tears	3	3
Death	3	3
Emotional Changes	3	3
Injury	2	2
Bone Fracture(s)	2	2
Confusion/ Disorientation	2	2
No Patient Involvement	2	2
Choking	2	2
Unintended Extubation	2	2
Loss of consciousness	2	2
Abrasion	1	1
Needle Stick/Puncture	1	1
Not Applicable	1	1
No Code Available	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Unspecified Tissue Injury	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Head Injury	1	1
Hemorrhage/Bleeding	1	1
Irritation	1	1
Laceration(s)	1	1
Damage to Ligament(s)	1	1
Pain	1	1
Paresis	1	1
Concussion	1	1
Ventilator Dependent	1	1
Reinfusion	1	1
Numbness	1	1
Fall	1	1
Anxiety	1	1