TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	222	222
Detachment of Device or Device Component	146	146
Material Split, Cut or Torn	77	78
Disconnection	37	37
Device Handling Problem	29	29
Use of Device Problem	26	26
Connection Problem	15	15
Material Integrity Problem	15	15
Gas/Air Leak	15	15
Material Twisted/Bent	13	13
Loose or Intermittent Connection	12	12
Patient Device Interaction Problem	12	12
Obstruction of Flow	11	11
Appropriate Term/Code Not Available	9	9
Material Separation	9	9
Loss of or Failure to Bond	8	8
Patient-Device Incompatibility	7	7
Leak/Splash	6	6
Material Too Soft/Flexible	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Material Puncture/Hole	5	5
Insufficient Information	5	5
Crack	4	5
Material Deformation	4	4
Defective Device	4	4
Device Dislodged or Dislocated	3	3
Inflation Problem	3	3
Insufficient Flow or Under Infusion	3	3
Material Too Rigid or Stiff	3	3
Contamination /Decontamination Problem	3	3
Contamination	3	3
Defective Component	3	3
Fire	3	3
Degraded	2	2
Fluid/Blood Leak	2	2
Pressure Problem	2	2
Blocked Connection	2	2
Infusion or Flow Problem	2	2
Partial Blockage	2	2
Failure to Unfold or Unwrap	2	2
Noise, Audible	1	1
Temperature Problem	1	1
Device Ingredient or Reagent Problem	1	1
Deformation Due to Compressive Stress	1	1
Failure to Disconnect	1	1
Unexpected Shutdown	1	1
Burst Container or Vessel	1	1
Suction Problem	1	1
Device Appears to Trigger Rejection	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	357	357
Low Oxygen Saturation	67	69
No Known Impact Or Consequence To Patient	58	58
Insufficient Information	29	29
No Consequences Or Impact To Patient	18	18
Hypoxia	11	11
Skin Inflammation/ Irritation	8	8
No Patient Involvement	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Pressure Sores	6	6
Hypersensitivity/Allergic reaction	6	6
Burn(s)	6	6
Rash	5	5
Unspecified Respiratory Problem	4	4
Tissue Breakdown	3	3
Headache	3	3
Partial thickness (Second Degree) Burn	3	3
Epistaxis	3	3
Fall	3	3
Bruise/Contusion	2	2
Decreased Respiratory Rate	2	2
Swelling/ Edema	2	2
Pain	2	2
Discomfort	2	2
Sinus Perforation	2	2
Aspiration/Inhalation	2	2
No Information	2	2
Superficial (First Degree) Burn	2	2
Swelling	1	1
Vomiting	1	1
Chest Pain	1	1
Injury	1	1
Burning Sensation	1	1
Dyspnea	1	1
Skin Erosion	1	1
Laceration(s)	1	1
Respiratory Acidosis	1	1
Bradycardia	1	1
Cough	1	1
Unspecified Tissue Injury	1	1
Obstruction/Occlusion	1	1
Hip Fracture	1	1
Hemorrhage/Bleeding	1	1
Death	1	1
Apnea	1	1
Loss of consciousness	1	1
Patient Problem/Medical Problem	1	1
Hearing Impairment	1	1
Cyanosis	1	1