TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	84	84
Device Slipped	36	36
Mechanical Problem	30	30
Adverse Event Without Identified Device or Use Problem	30	30
Material Split, Cut or Torn	15	15
Insufficient Information	10	10
Patient Device Interaction Problem	7	7
Defective Device	7	7
Positioning Problem	5	5
Material Integrity Problem	5	5
Material Frayed	5	5
Product Quality Problem	5	5
Defective Component	5	5
Material Disintegration	4	4
Labelling, Instructions for Use or Training Problem	4	4
Misassembled	4	4
Detachment of Device or Device Component	4	4
Fail-Safe Problem	3	3
Human-Device Interface Problem	3	3
Connection Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Material Separation	3	3
Inadequacy of Device Shape and/or Size	2	2
Unraveled Material	2	2
Activation, Positioning or Separation Problem	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	2	2
Appropriate Term/Code Not Available	2	2
Difficult or Delayed Separation	2	2
Material Too Soft/Flexible	1	1
Unintended Movement	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Off-Label Use	1	1
Crack	1	1
Disconnection	1	1
Inadequate Instructions for Healthcare Professional	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	123	123
No Consequences Or Impact To Patient	60	60
Extubate	21	21
Insufficient Information	19	19
No Known Impact Or Consequence To Patient	12	12
Irritability	5	5
Bruise/Contusion	4	4
Death	4	4
Emotional Changes	3	3
Skin Tears	3	3
Confusion/ Disorientation	2	2
Choking	2	2
No Patient Involvement	2	2
Unintended Extubation	2	2
Fall	2	2
Bone Fracture(s)	2	2
Loss of consciousness	2	2
Injury	2	2
Fracture, Arm	1	1
Ventilator Dependent	1	1
Anxiety	1	1
Complaint, Ill-Defined	1	1
Abrasion	1	1
Reinfusion	1	1
Numbness	1	1
Head Injury	1	1
Hemorrhage/Bleeding	1	1
Irritation	1	1
Laceration(s)	1	1
Damage to Ligament(s)	1	1
Pain	1	1
Paresis	1	1
Concussion	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Blood Loss	1	1
Needle Stick/Puncture	1	1
Not Applicable	1	1
No Information	1	1
No Code Available	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Unspecified Tissue Injury	1	1