TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	80	80
Device Slipped	38	38
Material Split, Cut or Torn	14	14
Mechanical Problem	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Insufficient Information	10	10
Patient Device Interaction Problem	8	8
Human-Device Interface Problem	5	5
Positioning Problem	5	5
Material Frayed	5	5
Labelling, Instructions for Use or Training Problem	5	5
Product Quality Problem	5	5
Defective Device	5	5
Defective Component	5	5
Detachment of Device or Device Component	4	4
Use of Device Problem	4	4
Material Disintegration	4	4
Device Handling Problem	3	3
Connection Problem	3	3
Material Integrity Problem	3	3
Activation, Positioning or Separation Problem	3	3
Fail-Safe Problem	3	3
Difficult or Delayed Separation	2	2
Appropriate Term/Code Not Available	2	2
Inadequate Instructions for Healthcare Professional	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	2	2
Disconnection	1	1
Difficult to Open or Close	1	1
Unintended Movement	1	1
Crack	1	1
Off-Label Use	1	1
Loose or Intermittent Connection	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Too Soft/Flexible	1	1
Protective Measures Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	147	147
Insufficient Information	24	24
No Consequences Or Impact To Patient	24	24
Irritability	6	6
Unspecified Mental, Emotional or Behavioural Problem	5	5
Unintended Extubation	5	5
No Known Impact Or Consequence To Patient	4	4
Death	3	3
Loss of consciousness	2	2
Choking	2	2
Extubate	2	2
Emotional Changes	2	2
Bone Fracture(s)	2	2
Confusion/ Disorientation	2	2
Head Injury	1	1
Anxiety	1	1
Hemorrhage/Bleeding	1	1
Aspiration/Inhalation	1	1
Numbness	1	1
Airway Obstruction	1	1
Fall	1	1
Foreign Body In Patient	1	1
Injury	1	1
Ventilator Dependent	1	1
Damage to Ligament(s)	1	1
Paresis	1	1
Pain	1	1
Concussion	1	1
Irritation	1	1
Unspecified Tissue Injury	1	1
Cardiac Arrest	1	1
Laceration(s)	1	1
Low Oxygen Saturation	1	1
Abrasion	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1