TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6126	6126
Crack	4512	4512
Corroded	3970	3970
Device Markings/Labelling Problem	3931	3931
Failure to Align	2484	2484
Contamination	1700	1700
Device Alarm System	1333	1333
Appropriate Term/Code Not Available	995	995
Deformation Due to Compressive Stress	904	904
Physical Resistance/Sticking	800	800
No Apparent Adverse Event	727	727
Device Sensing Problem	712	712
Naturally Worn	701	701
Inaccurate Delivery	659	659
Failure to Calibrate	614	614
Display Difficult to Read	572	572
Computer Software Problem	522	522
Circuit Failure	424	424
Misassembled	355	355
Excess Flow or Over-Infusion	343	343
Degraded	338	338
Insufficient Information	322	322
Calibration Problem	294	294
Application Program Freezes, Becomes Nonfunctional	246	246
Volume Accuracy Problem	231	231
Insufficient Flow or Under Infusion	214	214
Failure to Analyze Signal	178	178
Failure to Read Input Signal	174	174
Display or Visual Feedback Problem	157	157
Communication or Transmission Problem	152	152
Failure to Infuse	137	137
Infusion or Flow Problem	126	126
Failure to Sense	112	112
Material Integrity Problem	100	100
Improper Flow or Infusion	88	88
Air/Gas in Device	74	74
Mechanical Problem	70	70
Obstruction of Flow	68	68
Inaccurate Flow Rate	67	67
Use of Device Problem	58	58
Connection Problem	51	51
Electrical /Electronic Property Problem	49	49
False Alarm	49	49
Defective Component	48	48
Pumping Stopped	46	46
Failure to Deliver	46	46
Audible Prompt/Feedback Problem	45	45
Component Misassembled	45	45
Peeled/Delaminated	44	44
Defective Device	43	43

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14609	14609
No Patient Involvement	3414	3414
Insufficient Information	1281	1281
No Information	133	133
No Consequences Or Impact To Patient	115	115
No Known Impact Or Consequence To Patient	52	52
Pain	23	23
Cardiac Arrest	10	10
Fall	6	6
Oversedation	6	6
Low Oxygen Saturation	5	5
Increased Respiratory Rate	5	5
Death	4	4
Hypoglycemia	4	4
Numbness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Low Blood Pressure/ Hypotension	3	3
Inadequate Pain Relief	3	3
Underdose	3	3
Lethargy	2	2
Decreased Respiratory Rate	2	2
Hypoxia	2	2
Bradycardia	2	2
Overdose	2	2
Taste Disorder	2	2
Nausea	2	2
Hypersensitivity/Allergic reaction	2	2
Syncope/Fainting	2	2
High Blood Pressure/ Hypertension	2	2
Injury	1	1
Fever	1	1
Vomiting	1	1
Discomfort	1	1
Paresthesia	1	1
Dyspnea	1	1
Coma	1	1
Reaction to Medicinal Component of Device	1	1
Muscle Weakness	1	1
Dizziness	1	1
Diaphoresis	1	1
Unspecified Respiratory Problem	1	1
Respiratory Distress	1	1
Hemorrhage/Bleeding	1	1
Hypoesthesia	1	1
Respiratory Insufficiency	1	1
Pulmonary Hypertension	1	1
Bruise/Contusion	1	1