TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	81	81
Device Slipped	38	38
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
Defective Device	7	7
Patient Device Interaction Problem	7	7
Material Frayed	5	5
Defective Component	5	5
Material Integrity Problem	5	5
Positioning Problem	5	5
Product Quality Problem	5	5
Material Disintegration	4	4
Misassembled	4	4
Labelling, Instructions for Use or Training Problem	4	4
Detachment of Device or Device Component	4	4
Fail-Safe Problem	3	3
Connection Problem	3	3
Human-Device Interface Problem	3	3
Activation, Positioning or Separation Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Use of Device Problem	2	2
Difficult or Delayed Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
No Apparent Adverse Event	2	2
Protective Measures Problem	2	2
Appropriate Term/Code Not Available	2	2
Disconnection	1	1
Off-Label Use	1	1
Crack	1	1
Unintended Movement	1	1
Inadequate Instructions for Healthcare Professional	1	1
Structural Problem	1	1
Device Handling Problem	1	1
Material Separation	1	1
Material Too Soft/Flexible	1	1
Difficult to Open or Close	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	131	131
No Consequences Or Impact To Patient	51	51
Insufficient Information	21	21
Extubate	21	21
No Known Impact Or Consequence To Patient	6	6
Irritability	5	5
Death	3	3
Emotional Changes	3	3
Skin Tears	3	3
Bone Fracture(s)	2	2
Confusion/ Disorientation	2	2
Injury	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
No Patient Involvement	2	2
Choking	2	2
Loss of consciousness	2	2
Unintended Extubation	2	2
Damage to Ligament(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Not Applicable	1	1
No Code Available	1	1
Head Injury	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Irritation	1	1
Needle Stick/Puncture	1	1
Concussion	1	1
Numbness	1	1
Fall	1	1
Laceration(s)	1	1
Pain	1	1
Paresis	1	1
Anxiety	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1
Reinfusion	1	1
Ventilator Dependent	1	1