TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6433	6436
Crack	4718	4720
Corroded	4050	4054
Device Markings/Labelling Problem	3942	3943
Failure to Align	2516	2516
Contamination	1809	1812
Deformation Due to Compressive Stress	1733	1734
Device Sensing Problem	1478	1478
Device Alarm System	1471	1474
Failure to Infuse	1231	1231
Appropriate Term/Code Not Available	997	997
Physical Resistance/Sticking	885	885
Inaccurate Delivery	863	868
No Apparent Adverse Event	761	762
Naturally Worn	739	740
Degraded	735	735
Failure to Calibrate	698	704
Failure to Sense	601	601
Display Difficult to Read	579	579
Circuit Failure	578	578
Computer Software Problem	527	527
Excess Flow or Over-Infusion	433	438
Calibration Problem	426	436
Peeled/Delaminated	371	371
Misassembled	355	355
Insufficient Information	325	326
Insufficient Flow or Under Infusion	262	264
Application Program Freezes, Becomes Nonfunctional	247	247
Volume Accuracy Problem	227	230
Failure to Read Input Signal	227	229
Detachment of Device or Device Component	205	205
Improper Flow or Infusion	184	184
Failure to Analyze Signal	178	178
Display or Visual Feedback Problem	163	163
Obstruction of Flow	161	161
Communication or Transmission Problem	156	156
Air/Gas in Device	147	148
Inaccurate Flow Rate	141	141
Infusion or Flow Problem	121	123
False Alarm	111	111
Mechanical Problem	102	102
Material Integrity Problem	100	100
Complete Blockage	96	96
Wireless Communication Problem	95	95
Defective Component	91	91
Use of Device Problem	86	88
Material Split, Cut or Torn	80	80
Failure to Deliver	80	81
Pumping Stopped	79	79
Pressure Problem	76	76

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19557	19591
No Patient Involvement	3371	3372
Insufficient Information	1331	1346
No Consequences Or Impact To Patient	88	89
No Information	78	78
Pain	38	39
No Known Impact Or Consequence To Patient	16	16
Cardiac Arrest	11	11
Low Blood Pressure/ Hypotension	9	9
Oversedation	7	7
Increased Respiratory Rate	7	7
Nausea	6	6
Numbness	6	6
Fall	6	6
Low Oxygen Saturation	6	7
Hypoglycemia	4	4
Inadequate Pain Relief	4	4
Underdose	3	3
Dizziness	3	3
Lethargy	3	3
Dyspnea	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Bradycardia	2	2
High Blood Pressure/ Hypertension	2	2
Decreased Respiratory Rate	2	2
Syncope/Fainting	2	3
Headache	2	2
Hypersensitivity/Allergic reaction	2	2
Discomfort	2	2
Pulmonary Hypertension	2	2
Diaphoresis	2	2
Hypoxia	2	2
Taste Disorder	2	2
Pallor	1	1
Cancer	1	1
Respiratory Distress	1	1
Overdose	1	1
Peripheral Edema	1	1
Injury	1	1
Muscle Weakness	1	1
Hypoesthesia	1	1
Vertigo	1	1
Fever	1	1
Tachycardia	1	1
Hemorrhage/Bleeding	1	1
Death	1	1
Chest Pain	1	1
Ulcer	1	1
Dysgeusia	1	1
Reaction to Medicinal Component of Device	1	1