TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	77	77
Device Slipped	35	35
Material Split, Cut or Torn	14	14
Mechanical Problem	11	11
Insufficient Information	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Patient Device Interaction Problem	8	8
Material Frayed	5	5
Defective Component	5	5
Defective Device	5	5
Positioning Problem	5	5
Product Quality Problem	5	5
Human-Device Interface Problem	5	5
Material Disintegration	4	4
Use of Device Problem	4	4
Labelling, Instructions for Use or Training Problem	4	4
Detachment of Device or Device Component	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
Therapeutic or Diagnostic Output Failure	2	2
Difficult or Delayed Separation	2	2
No Apparent Adverse Event	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
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Protective Measures Problem	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	142	142
No Consequences Or Impact To Patient	24	24
Insufficient Information	23	23
Irritability	6	6
Unspecified Mental, Emotional or Behavioural Problem	5	5
No Known Impact Or Consequence To Patient	4	4
Death	3	3
Unintended Extubation	3	3
Emotional Changes	2	2
Bone Fracture(s)	2	2
Confusion/ Disorientation	2	2
Choking	2	2
Extubate	2	2
Loss of consciousness	2	2
Damage to Ligament(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Aspiration/Inhalation	1	1
Head Injury	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Irritation	1	1
Injury	1	1
Foreign Body In Patient	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
Airway Obstruction	1	1
Ventilator Dependent	1	1
Low Oxygen Saturation	1	1