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
Material Disintegration	4	4
Material Rupture	4	4
Misassembled	4	4
Connection Problem	3	3
Use of Device Problem	3	3
Fail-Safe Problem	3	3
Stretched	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
Inadequacy of Device Shape and/or Size	2	2
No Apparent Adverse Event	2	2
Therapeutic or Diagnostic Output Failure	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
Device Emits Odor	1	1
Difficult to Remove	1	1
Moisture Damage	1	1
Sticking	1	1
Tear, Rip or Hole in Device Packaging	1	1
Inadequate Instructions for Healthcare Professional	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