TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6346	6346
Crack	4684	4684
Corroded	4027	4027
Device Markings/Labelling Problem	3935	3935
Failure to Align	2511	2511
Contamination	1789	1789
Deformation Due to Compressive Stress	1700	1700
Device Alarm System	1436	1436
Device Sensing Problem	1303	1303
Failure to Infuse	1031	1031
Appropriate Term/Code Not Available	996	996
Physical Resistance/Sticking	867	867
Inaccurate Delivery	796	796
No Apparent Adverse Event	746	746
Naturally Worn	726	726
Failure to Calibrate	691	691
Degraded	639	639
Display Difficult to Read	579	579
Circuit Failure	531	531
Computer Software Problem	527	527
Failure to Sense	484	484
Calibration Problem	387	387
Excess Flow or Over-Infusion	376	376
Misassembled	355	355
Peeled/Delaminated	348	348
Insufficient Information	323	323
Application Program Freezes, Becomes Nonfunctional	246	246
Insufficient Flow or Under Infusion	234	234
Volume Accuracy Problem	222	222
Failure to Read Input Signal	207	207
Failure to Analyze Signal	178	178
Improper Flow or Infusion	165	165
Display or Visual Feedback Problem	161	161
Communication or Transmission Problem	156	156
Air/Gas in Device	133	133
Detachment of Device or Device Component	132	132
Inaccurate Flow Rate	128	128
Obstruction of Flow	127	127
Infusion or Flow Problem	113	113
Material Integrity Problem	100	100
False Alarm	94	94
Mechanical Problem	93	93
Wireless Communication Problem	88	88
Defective Component	76	76
Use of Device Problem	76	76
Pumping Stopped	75	75
Connection Problem	67	67
Electrical /Electronic Property Problem	66	66
Material Split, Cut or Torn	66	66
Failure to Deliver	63	63

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18391	18391
No Patient Involvement	3371	3371
Insufficient Information	1315	1315
No Consequences Or Impact To Patient	88	88
No Information	78	78
Pain	30	30
No Known Impact Or Consequence To Patient	16	16
Cardiac Arrest	11	11
Increased Respiratory Rate	7	7
Low Oxygen Saturation	6	6
Fall	6	6
Oversedation	6	6
Low Blood Pressure/ Hypotension	5	5
Nausea	5	5
Hypoglycemia	4	4
Numbness	4	4
Lethargy	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Dizziness	3	3
Underdose	3	3
Decreased Respiratory Rate	2	2
Headache	2	2
Inadequate Pain Relief	2	2
Bradycardia	2	2
Dyspnea	2	2
Taste Disorder	2	2
Hypersensitivity/Allergic reaction	2	2
Syncope/Fainting	2	2
High Blood Pressure/ Hypertension	2	2
Pallor	1	1
Paralysis	1	1
Vomiting	1	1
Fever	1	1
Discomfort	1	1
Vertigo	1	1
Chest Pain	1	1
Diarrhea	1	1
Injury	1	1
Coma	1	1
Paresthesia	1	1
Overdose	1	1
Peripheral Edema	1	1
Reaction to Medicinal Component of Device	1	1
Swelling/ Edema	1	1
Tachycardia	1	1
Muscle Weakness	1	1
Hypoxia	1	1
Unspecified Respiratory Problem	1	1
Ulcer	1	1
Diaphoresis	1	1