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
Patient Device Interaction Problem	7	7
Defective Device	7	7
Product Quality Problem	5	5
Material Frayed	5	5
Positioning Problem	5	5
Defective Component	5	5
Material Integrity Problem	5	5
Detachment of Device or Device Component	4	4
Labelling, Instructions for Use or Training Problem	4	4
Misassembled	4	4
Material Disintegration	4	4
Fail-Safe Problem	3	3
Human-Device Interface Problem	3	3
Connection Problem	3	3
Inadequacy of Device Shape and/or Size	2	2
No Apparent Adverse Event	2	2
Use of Device Problem	2	2
Difficult or Delayed Separation	2	2
Activation, Positioning or Separation Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Appropriate Term/Code Not Available	2	2
Protective Measures Problem	2	2
Off-Label Use	1	1
Inadequate Instructions for Healthcare Professional	1	1
Structural Problem	1	1
Material Separation	1	1
Difficult to Open or Close	1	1
Device Handling Problem	1	1
Disconnection	1	1
Crack	1	1
Unintended Movement	1	1
Material Too Soft/Flexible	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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Damage to Ligament(s)	1	1
Not Applicable	1	1
No Code Available	1	1
Head Injury	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Needle Stick/Puncture	1	1
Irritation	1	1
Numbness	1	1
Concussion	1	1
Laceration(s)	1	1
Paresis	1	1
Fall	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Anxiety	1	1
Reinfusion	1	1
Hemorrhage/Bleeding	1	1
Ventilator Dependent	1	1