TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6155	6155
Crack	4518	4518
Corroded	3977	3977
Device Markings/Labelling Problem	3931	3931
Failure to Align	2485	2485
Contamination	1709	1709
Device Alarm System	1343	1343
Appropriate Term/Code Not Available	995	995
Deformation Due to Compressive Stress	917	917
Physical Resistance/Sticking	803	803
Device Sensing Problem	785	785
No Apparent Adverse Event	727	727
Naturally Worn	706	706
Inaccurate Delivery	667	667
Failure to Calibrate	619	619
Display Difficult to Read	572	572
Computer Software Problem	523	523
Circuit Failure	438	438
Degraded	364	364
Excess Flow or Over-Infusion	363	363
Misassembled	355	355
Insufficient Information	322	322
Calibration Problem	305	305
Failure to Infuse	279	279
Application Program Freezes, Becomes Nonfunctional	246	246
Volume Accuracy Problem	233	233
Insufficient Flow or Under Infusion	218	218
Failure to Analyze Signal	178	178
Failure to Read Input Signal	174	174
Display or Visual Feedback Problem	158	158
Communication or Transmission Problem	152	152
Failure to Sense	151	151
Infusion or Flow Problem	126	126
Material Integrity Problem	100	100
Improper Flow or Infusion	99	99
Air/Gas in Device	82	82
Obstruction of Flow	81	81
Inaccurate Flow Rate	81	81
Mechanical Problem	70	70
Peeled/Delaminated	67	67
Defective Component	67	67
Use of Device Problem	64	64
False Alarm	55	55
Connection Problem	51	51
Electrical /Electronic Property Problem	49	49
Pumping Stopped	47	47
Failure to Deliver	46	46
Component Misassembled	46	46
Audible Prompt/Feedback Problem	45	45
Defective Device	44	44

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15049	15049
No Patient Involvement	3414	3414
Insufficient Information	1285	1285
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	11	11
Oversedation	6	6
Fall	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
Nausea	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
Hypersensitivity/Allergic reaction	2	2
Syncope/Fainting	2	2
High Blood Pressure/ Hypertension	2	2
Injury	1	1
Vomiting	1	1
Discomfort	1	1
Fever	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
Unspecified Respiratory Problem	1	1
Diaphoresis	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