TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	61	61
Device Slipped	37	37
Material Split, Cut or Torn	11	11
Mechanical Problem	11	11
Insufficient Information	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Patient Device Interaction Problem	7	7
Material Frayed	5	5
Defective Component	5	5
Use of Device Problem	5	5
Labelling, Instructions for Use or Training Problem	5	5
Material Disintegration	4	4
Defective Device	4	4
Positioning Problem	4	4
Product Quality Problem	4	4
Human-Device Interface Problem	4	4
Difficult to Open or Close	4	4
Activation, Positioning or Separation Problem	3	3
Material Integrity Problem	3	3
Fail-Safe Problem	3	3
Device Handling Problem	3	3
Connection Problem	3	3
Material Puncture/Hole	2	2
Difficult or Delayed Separation	2	2
Appropriate Term/Code Not Available	2	2
Disconnection	1	1
Off-Label Use	1	1
Crack	1	1
Unintended Movement	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inadequate Instructions for Healthcare Professional	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Detachment of Device or Device Component	1	1
Device Dislodged or Dislocated	1	1
Protective Measures Problem	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	152	152
Insufficient Information	22	22
Irritability	6	6
Unspecified Mental, Emotional or Behavioural Problem	5	5
Unintended Extubation	5	5
Emotional Changes	2	2
Bone Fracture(s)	2	2
Choking	2	2
No Consequences Or Impact To Patient	2	2
Loss of consciousness	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Damage to Ligament(s)	1	1
Death	1	1
Head Injury	1	1
Aspiration/Inhalation	1	1
Abrasion	1	1
Confusion/ Disorientation	1	1
Cardiac Arrest	1	1
Foreign Body In Patient	1	1
Needle Stick/Puncture	1	1
Numbness	1	1
Concussion	1	1
Paresis	1	1
Fall	1	1
Pain	1	1
Laceration(s)	1	1
Unspecified Tissue Injury	1	1
Anxiety	1	1
Extubate	1	1
Ventilator Dependent	1	1
Low Oxygen Saturation	1	1
Airway Obstruction	1	1