TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	217	217
Detachment of Device or Device Component	136	136
Material Split, Cut or Torn	76	76
Disconnection	36	36
Device Handling Problem	29	29
Use of Device Problem	25	25
Material Integrity Problem	13	13
Gas/Air Leak	12	12
Connection Problem	10	10
Material Separation	9	9
Patient Device Interaction Problem	8	8
Material Twisted/Bent	7	7
Leak/Splash	6	6
Loss of or Failure to Bond	6	6
Appropriate Term/Code Not Available	6	6
Obstruction of Flow	6	6
Patient-Device Incompatibility	6	6
Loose or Intermittent Connection	5	5
Material Too Soft/Flexible	5	5
Insufficient Information	5	5
Material Deformation	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Crack	4	4
Contamination	3	3
Contamination /Decontamination Problem	3	3
Material Too Rigid or Stiff	3	3
Material Puncture/Hole	3	3
Inflation Problem	3	3
Fire	3	3
Device Dislodged or Dislocated	3	3
Defective Device	2	2
Defective Component	2	2
Degraded	2	2
Fluid/Blood Leak	2	2
Infusion or Flow Problem	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
Pressure Problem	1	1
Unexpected Shutdown	1	1
Burst Container or Vessel	1	1
Suction Problem	1	1
Device Appears to Trigger Rejection	1	1
Inaccurate Delivery	1	1
No Apparent Adverse Event	1	1
Device Contamination with Chemical or Other Material	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	326	326
No Known Impact Or Consequence To Patient	58	58
Low Oxygen Saturation	53	53
Insufficient Information	24	24
No Consequences Or Impact To Patient	18	18
Skin Inflammation/ Irritation	8	8
Hypoxia	8	8
No Patient Involvement	7	7
Hypersensitivity/Allergic reaction	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pressure Sores	5	5
Burn(s)	5	5
Rash	4	4
Unspecified Respiratory Problem	4	4
Tissue Breakdown	3	3
Epistaxis	3	3
Headache	3	3
Partial thickness (Second Degree) Burn	3	3
Bruise/Contusion	2	2
Superficial (First Degree) Burn	2	2
Decreased Respiratory Rate	2	2
No Information	2	2
Aspiration/Inhalation	2	2
Sinus Perforation	2	2
Swelling/ Edema	2	2
Fall	2	2
Pain	2	2
Loss of consciousness	1	1
Hemorrhage/Bleeding	1	1
Unspecified Tissue Injury	1	1
Cough	1	1
Bradycardia	1	1
Laceration(s)	1	1
Dyspnea	1	1
Vomiting	1	1
Swelling	1	1
Chest Pain	1	1
Injury	1	1
Burning Sensation	1	1
Respiratory Acidosis	1	1
Obstruction/Occlusion	1	1
Death	1	1
Apnea	1	1
Patient Problem/Medical Problem	1	1
Hearing Impairment	1	1
Cyanosis	1	1