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	39	39
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
Use of Device Problem	5	5
Labelling, Instructions for Use or Training Problem	5	5
Product Quality Problem	5	5
Human-Device Interface Problem	5	5
Material Disintegration	4	4
Detachment of Device or Device Component	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
Therapeutic or Diagnostic Output Failure	2	2
Inadequate Instructions for Healthcare Professional	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
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Dislodged or Dislocated	1	1
Protective Measures Problem	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	154	154
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
Emotional Changes	2	2
Bone Fracture(s)	2	2
Confusion/ Disorientation	2	2
Laceration(s)	2	2
Choking	2	2
Extubate	2	2
Loss of consciousness	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Damage to Ligament(s)	1	1
No Code Available	1	1
Head Injury	1	1
Aspiration/Inhalation	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Injury	1	1
Irritation	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
Unspecified Tissue Injury	1	1
Anxiety	1	1
Hemorrhage/Bleeding	1	1
Ventilator Dependent	1	1
Low Oxygen Saturation	1	1
Airway Obstruction	1	1