TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6265	6265
Crack	4578	4578
Corroded	4002	4002
Device Markings/Labelling Problem	3932	3932
Failure to Align	2486	2486
Contamination	1757	1757
Deformation Due to Compressive Stress	1660	1660
Device Alarm System	1381	1381
Device Sensing Problem	1041	1041
Appropriate Term/Code Not Available	995	995
Physical Resistance/Sticking	857	857
No Apparent Adverse Event	731	731
Naturally Worn	714	714
Inaccurate Delivery	691	691
Failure to Calibrate	654	654
Failure to Infuse	635	635
Display Difficult to Read	574	574
Computer Software Problem	524	524
Circuit Failure	468	468
Degraded	451	452
Misassembled	355	355
Calibration Problem	342	342
Excess Flow or Over-Infusion	335	335
Insufficient Information	323	323
Failure to Sense	278	278
Application Program Freezes, Becomes Nonfunctional	246	246
Volume Accuracy Problem	216	216
Insufficient Flow or Under Infusion	197	197
Failure to Read Input Signal	184	184
Failure to Analyze Signal	178	178
Peeled/Delaminated	161	161
Display or Visual Feedback Problem	159	159
Communication or Transmission Problem	154	154
Improper Flow or Infusion	144	144
Infusion or Flow Problem	103	103
Air/Gas in Device	102	102
Material Integrity Problem	100	100
Obstruction of Flow	98	98
Inaccurate Flow Rate	97	97
Mechanical Problem	81	81
False Alarm	76	76
Defective Component	75	75
Use of Device Problem	66	66
Detachment of Device or Device Component	62	62
Connection Problem	60	60
Defective Device	59	59
Pumping Stopped	53	53
Electrical /Electronic Property Problem	51	51
Battery Problem	50	50
Component Misassembled	48	48

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16516	16517
No Patient Involvement	3371	3371
Insufficient Information	1297	1297
No Consequences Or Impact To Patient	88	88
No Information	78	78
Pain	24	24
No Known Impact Or Consequence To Patient	16	16
Cardiac Arrest	11	11
Oversedation	6	6
Fall	6	6
Increased Respiratory Rate	6	6
Low Blood Pressure/ Hypotension	5	5
Low Oxygen Saturation	5	5
Numbness	4	4
Hypoglycemia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Nausea	3	3
Underdose	3	3
High Blood Pressure/ Hypertension	2	2
Syncope/Fainting	2	2
Lethargy	2	2
Hypersensitivity/Allergic reaction	2	2
Decreased Respiratory Rate	2	2
Taste Disorder	2	2
Inadequate Pain Relief	2	2
Bradycardia	2	2
Bruise/Contusion	1	1
Dysgeusia	1	1
Tinnitus	1	1
Cancer	1	1
Hemorrhage/Bleeding	1	1
Respiratory Insufficiency	1	1
Hypoesthesia	1	1
Unspecified Respiratory Problem	1	1
Hypoxia	1	1
Dyspnea	1	1
Coma	1	1
Vertigo	1	1
Discomfort	1	1
Vomiting	1	1
Fever	1	1
Injury	1	1
Paresthesia	1	1
Overdose	1	1
Reaction to Medicinal Component of Device	1	1
Muscle Weakness	1	1
Dizziness	1	1
Diaphoresis	1	1
Respiratory Distress	1	1
Death	1	1