TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	288	288
Detachment of Device or Device Component	173	173
Device Handling Problem	123	123
Material Split, Cut or Torn	104	104
Disconnection	91	91
Device Issue	87	87
Detachment Of Device Component	43	43
Split	41	41
Kinked	39	39
Leak/Splash	38	38
Material Separation	37	37
Hole In Material	36	36
Use of Device Problem	34	34
Material Integrity Problem	27	27
Adverse Event Without Identified Device or Use Problem	23	23
Connection Problem	18	18
Device Operates Differently Than Expected	16	16
Improper or Incorrect Procedure or Method	15	15
Gas/Air Leak	15	15
Torn Material	14	14
Patient-Device Incompatibility	14	14
Improper Flow or Infusion	14	14
Folded	12	12
Insufficient Information	11	11
No Flow	11	11
Device Sensing Problem	10	10
Obstruction of Flow	9	9
Loose or Intermittent Connection	9	9
Patient Device Interaction Problem	9	9
Material Deformation	8	8
Defective Device	8	8
Bent	8	8
Appropriate Term/Code Not Available	8	8
Device Contamination with Chemical or Other Material	7	7
Material Twisted/Bent	7	7
Loss of or Failure to Bond	7	7
Complete Blockage	6	6
Crack	6	6
Device Damaged Prior to Use	6	6
Device Dislodged or Dislocated	6	6
Material Puncture/Hole	5	5
Device Emits Odor	4	4
Infusion or Flow Problem	4	4
No Apparent Adverse Event	4	4
Misassembled	4	4
Deformation Due to Compressive Stress	4	4
Degraded	4	4
Unraveled Material	4	4
Inflation Problem	3	3
Malposition of Device	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	338	338
No Consequences Or Impact To Patient	319	319
No Known Impact Or Consequence To Patient	262	262
Low Oxygen Saturation	143	143
No Patient Involvement	61	61
Respiratory Distress	36	36
Insufficient Information	21	21
Pressure Sores	21	21
No Information	14	14
Injury	13	13
Death	12	12
Hypoxia	11	11
Skin Inflammation/ Irritation	8	8
Pain	7	7
Fall	7	7
Burn(s)	6	6
Rash	6	6
Hypersensitivity/Allergic reaction	6	6
No Code Available	6	6
Dyspnea	5	5
Skin Irritation	5	5
Tissue Breakdown	5	5
Unspecified Respiratory Problem	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Superficial (First Degree) Burn	4	4
Increased Respiratory Rate	3	3
Bradycardia	3	3
Reaction	3	3
Complaint, Ill-Defined	3	3
High Oxygen Saturation	3	3
Decreased Respiratory Rate	3	3
Erythema	3	3
Bruise/Contusion	3	3
Partial thickness (Second Degree) Burn	2	2
Skin Tears	2	2
Swelling/ Edema	2	2
Hemorrhage/Bleeding	2	2
Headache	2	2
Laceration(s)	2	2
Swelling	2	2
Discomfort	2	2
Burning Sensation	2	2
Skin Erosion	2	2
Patient Problem/Medical Problem	2	2
Hip Fracture	2	2
Sinus Perforation	2	2
Perforation	2	2
Lethargy	1	1
Increased Sensitivity	1	1
Excessive Tear Production	1	1