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
Improper or Incorrect Procedure or Method	12	12
Material Integrity Problem	12	12
Device Contaminated During Manufacture or Shipping	11	11
Defective Device	9	9
Material Separation	9	9
Defective Component	8	8
Detachment Of Device Component	7	7
Patient Device Interaction Problem	7	7
Detachment of Device or Device Component	6	6
Product Quality Problem	6	6
Mechanics Altered	6	6
Material Frayed	5	5
Positioning Problem	5	5
Labelling, Instructions for Use or Training Problem	5	5
Difficult to Open or Close	4	4
Human-Device Interface Problem	4	4
Misassembled	4	4
Material Rupture	4	4
Material Disintegration	4	4
Fail-Safe Problem	3	3
Use of Device Problem	3	3
Stretched	3	3
Connection Problem	3	3
Unraveled Material	2	2
Degraded	2	2
Device Handling Problem	2	2
Difficult or Delayed Separation	2	2
Microbial Contamination of Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	2	2
Inadequacy of Device Shape and/or Size	2	2
Protective Measures Problem	2	2
Appropriate Term/Code Not Available	2	2
Activation, Positioning or Separation Problem	2	2
Device Difficult to Setup or Prepare	1	1
Structural Problem	1	1
Difficult to Remove	1	1
Moisture Damage	1	1
Inadequate Instructions for Healthcare Professional	1	1
Device Emits Odor	1	1
Tear, Rip or Hole in Device Packaging	1	1
Sticking	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
Not Applicable	6	6
Skin Tears	6	6
Irritability	5	5
Emotional Changes	5	5
Bruise/Contusion	4	4
Skin Erosion	4	4
Loss of consciousness	3	3
Bone Fracture(s)	3	3
Confusion/ Disorientation	3	3
Injury	3	3
Unintended Extubation	2	2
Anxiety	2	2
Choking	2	2
Laceration(s)	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
Skin Irritation	2	2
Irritation	1	1
Needle Stick/Puncture	1	1
Numbness	1	1
Concussion	1	1
Cardiac Arrest	1	1
Abrasion	1	1
Cardiopulmonary Arrest	1	1
Paresis	1	1
Pain	1	1
Blood Loss	1	1
Head Injury	1	1
Unspecified Tissue Injury	1	1
Therapeutic Response, Decreased	1	1
Hematoma	1	1
Complaint, Ill-Defined	1	1
Sweating	1	1
Reinfusion	1	1
Hemorrhage/Bleeding	1	1
Damage to Ligament(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Ventilator Dependent	1	1
Device Embedded In Tissue or Plaque	1	1
Fracture, Arm	1	1