TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	125	125
Adverse Event Without Identified Device or Use Problem	47	47
Device Slipped	43	43
Mechanical Problem	30	30
Insufficient Information	18	18
Material Split, Cut or Torn	15	15
Device Operates Differently Than Expected	14	14
Torn Material	13	13
Material Integrity Problem	12	12
Improper or Incorrect Procedure or Method	12	12
Device Contaminated During Manufacture or Shipping	11	11
Defective Device	9	9
Material Separation	9	9
Defective Component	8	8
Patient Device Interaction Problem	7	7
Detachment Of Device Component	7	7
Product Quality Problem	6	6
Detachment of Device or Device Component	6	6
Mechanics Altered	6	6
Positioning Problem	5	5
Labelling, Instructions for Use or Training Problem	5	5
Material Frayed	5	5
Material Disintegration	4	4
Difficult to Open or Close	4	4
Human-Device Interface Problem	4	4
Misassembled	4	4
Material Rupture	4	4
Fail-Safe Problem	3	3
Stretched	3	3
Use of Device Problem	3	3
Connection Problem	3	3
Appropriate Term/Code Not Available	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Handling Problem	2	2
Difficult or Delayed Separation	2	2
Activation, Positioning or Separation Problem	2	2
Degraded	2	2
Unraveled Material	2	2
Microbial Contamination of Device	2	2
Structural Problem	1	1
Off-Label Use	1	1
Disconnection	1	1
Loose or Intermittent Connection	1	1
Nonstandard Device	1	1
Material Too Soft/Flexible	1	1
Escape	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	131	131
No Consequences Or Impact To Patient	95	95
No Known Impact Or Consequence To Patient	59	59
Extubate	34	34
Insufficient Information	21	21
No Patient Involvement	15	15
Fall	12	12
No Code Available	10	10
No Information	9	9
Death	6	6
Skin Tears	6	6
Not Applicable	6	6
Irritability	5	5
Emotional Changes	5	5
Bruise/Contusion	4	4
Skin Erosion	4	4
Loss of consciousness	3	3
Injury	3	3
Confusion/ Disorientation	3	3
Bone Fracture(s)	3	3
Unspecified Mental, Emotional or Behavioural Problem	2	2
Laceration(s)	2	2
Choking	2	2
Anxiety	2	2
Skin Irritation	2	2
Unintended Extubation	2	2
Cardiac Arrest	1	1
Irritation	1	1
Blood Loss	1	1
Abrasion	1	1
Needle Stick/Puncture	1	1
Concussion	1	1
Numbness	1	1
Hematoma	1	1
Head Injury	1	1
Cardiopulmonary Arrest	1	1
Pain	1	1
Paresis	1	1
Unspecified Tissue Injury	1	1
Therapeutic Response, Decreased	1	1
Hemorrhage/Bleeding	1	1
Sweating	1	1
Complaint, Ill-Defined	1	1
Reinfusion	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Fracture, Arm	1	1
Ventilator Dependent	1	1
Damage to Ligament(s)	1	1
Device Embedded In Tissue or Plaque	1	1