TPLC - Total Product Life Cycle

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Device	catheter, oximeter, fiber-optic
Product Code	DQE
Regulation Number	870.1230
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	80	80
Material Rupture	55	55
Incorrect Measurement	29	29
Fluid/Blood Leak	22	22
Adverse Event Without Identified Device or Use Problem	16	16
Leak/Splash	13	13
Material Split, Cut or Torn	11	11
Deflation Problem	9	9
Appropriate Term/Code Not Available	9	9
Material Separation	8	8
Material Fragmentation	8	8
Unable to Obtain Readings	7	7
Inflation Problem	6	6
Break	6	6
Difficult to Insert	5	5
No Device Output	5	5
Detachment of Device or Device Component	5	5
Physical Resistance/Sticking	4	4
Output Problem	3	3
Insufficient Information	2	2
Defective Device	2	2
Display or Visual Feedback Problem	2	2
Device Displays Incorrect Message	2	2
Difficult to Remove	2	2
Microbial Contamination of Device	2	2
Increase in Pressure	2	2
Obstruction of Flow	2	2
Insufficient Flow or Under Infusion	2	2
Device Contamination with Chemical or Other Material	2	2
Malposition of Device	2	2
Difficult or Delayed Positioning	2	2
Temperature Problem	2	2
Overheating of Device	1	1
Human-Device Interface Problem	1	1
Deformation Due to Compressive Stress	1	1
Protective Measures Problem	1	1
Failure to Advance	1	1
Pacing Problem	1	1
Component Misassembled	1	1
Output below Specifications	1	1
Inadequacy of Device Shape and/or Size	1	1
Retraction Problem	1	1
High Test Results	1	1
Infusion or Flow Problem	1	1
Material Twisted/Bent	1	1
Gas/Air Leak	1	1
Positioning Failure	1	1
No Pressure	1	1
Contamination /Decontamination Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143	143
No Consequences Or Impact To Patient	90	90
No Known Impact Or Consequence To Patient	45	45
Insufficient Information	12	12
Hemorrhage/Bleeding	11	11
Blood Loss	5	5
Hypersensitivity/Allergic reaction	4	4
Foreign Body In Patient	4	4
No Patient Involvement	4	4
Low Blood Pressure/ Hypotension	4	4
Unspecified Infection	3	4
Shaking/Tremors	3	3
Perforation of Vessels	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Perforation	2	2
Fever	2	2
Chills	2	2
High Blood Pressure/ Hypertension	1	1
Arrhythmia	1	1
No Code Available	1	1
Respiratory Distress	1	1
No Information	1	1
Hemoptysis	1	1
Alteration In Body Temperature	1	1
Cardiac Arrest	1	1
Ventricular Fibrillation	1	1
Needle Stick/Puncture	1	1
Cardiac Perforation	1	1
Thrombosis	1	1
Reaction	1	1
Swelling/ Edema	1	1
Tachycardia	1	1
Thrombus	1	1
Hemothorax	1	1