TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5301	5303
Corroded	3528	3531
Crack	3330	3331
Device Markings/Labelling Problem	2972	2972
Failure to Align	2518	2518
Contamination	1740	1743
Device Alarm System	1506	1509
Device Sensing Problem	1459	1459
Failure to Infuse	1396	1396
Deformation Due to Compressive Stress	1307	1307
Inaccurate Delivery	874	879
Physical Resistance/Sticking	798	798
No Apparent Adverse Event	658	659
Failure to Sense	656	656
Degraded	654	654
Failure to Calibrate	617	623
Appropriate Term/Code Not Available	576	576
Display Difficult to Read	554	554
Circuit Failure	517	517
Calibration Problem	443	453
Computer Software Problem	432	432
Naturally Worn	432	432
Excess Flow or Over-Infusion	431	436
Peeled/Delaminated	375	375
Insufficient Information	292	293
Insufficient Flow or Under Infusion	286	288
Detachment of Device or Device Component	228	228
Volume Accuracy Problem	217	220
Failure to Read Input Signal	211	213
Application Program Freezes, Becomes Nonfunctional	207	207
Obstruction of Flow	190	190
Improper Flow or Infusion	189	189
Air/Gas in Device	159	160
Misassembled	149	149
Inaccurate Flow Rate	147	147
Communication or Transmission Problem	145	145
Mechanical Problem	120	120
Complete Blockage	120	120
False Alarm	116	116
Defective Component	108	108
Wireless Communication Problem	101	101
Material Integrity Problem	101	101
Material Split, Cut or Torn	97	97
Use of Device Problem	95	97
Infusion or Flow Problem	94	96
Failure to Analyze Signal	90	90
Electrical /Electronic Property Problem	89	90
Pressure Problem	89	89
Failure to Deliver	87	88
Pumping Stopped	75	75

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20449	20483
Insufficient Information	1348	1363
No Patient Involvement	1185	1185
Pain	43	44
No Consequences Or Impact To Patient	20	21
No Information	19	19
Cardiac Arrest	10	10
Low Blood Pressure/ Hypotension	8	8
Increased Respiratory Rate	7	7
Oversedation	7	7
Numbness	7	7
Nausea	6	6
Fall	6	6
Lethargy	4	4
Low Oxygen Saturation	4	5
Inadequate Pain Relief	4	4
Hypoglycemia	4	4
Dyspnea	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Dizziness	3	3
Decreased Respiratory Rate	2	2
Headache	2	2
Hypoxia	2	2
Discomfort	2	2
Taste Disorder	2	2
Diaphoresis	2	2
Hypersensitivity/Allergic reaction	2	2
Pulmonary Hypertension	2	2
Syncope/Fainting	2	3
Pallor	1	1
Paralysis	1	1
Chest Pain	1	1
Diarrhea	1	1
Vertigo	1	1
Vomiting	1	1
Fever	1	1
Paresthesia	1	1
Peripheral Edema	1	1
Awareness during Anaesthesia	1	1
Coma	1	1
Reaction to Medicinal Component of Device	1	1
Bradycardia	1	1
Muscle Weakness	1	1
Tachycardia	1	1
Swelling/ Edema	1	1
Ulcer	1	1
Unspecified Respiratory Problem	1	1
Fetal Distress	1	1
Death	1	1
Hemorrhage/Bleeding	1	1