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	78	78
Material Rupture	55	55
Incorrect Measurement	28	28
Fluid/Blood Leak	19	19
Adverse Event Without Identified Device or Use Problem	16	16
Material Split, Cut or Torn	12	12
Leak/Splash	12	12
Appropriate Term/Code Not Available	9	9
Deflation Problem	9	9
Material Separation	9	9
Material Fragmentation	8	8
Unable to Obtain Readings	7	7
Inflation Problem	6	6
Break	6	6
Difficult to Insert	5	5
Detachment of Device or Device Component	5	5
Physical Resistance/Sticking	4	4
Output Problem	3	3
Increase in Pressure	2	2
Difficult or Delayed Positioning	2	2
Defective Device	2	2
Insufficient Information	2	2
No Device Output	2	2
Temperature Problem	2	2
Device Displays Incorrect Message	2	2
Display or Visual Feedback Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Insufficient Flow or Under Infusion	2	2
Obstruction of Flow	2	2
Difficult to Remove	2	2
Microbial Contamination of Device	2	2
Malposition of Device	2	2
Retraction Problem	1	1
Infusion or Flow Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Positioning Failure	1	1
Component Misassembled	1	1
Failure to Deflate	1	1
Human-Device Interface Problem	1	1
Deformation Due to Compressive Stress	1	1
Material Twisted/Bent	1	1
Gas/Air Leak	1	1
No Pressure	1	1
Contamination /Decontamination Problem	1	1
Output below Specifications	1	1
Material Puncture/Hole	1	1
Unintended Movement	1	1
Difficult to Advance	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	134	134
No Consequences Or Impact To Patient	90	90
No Known Impact Or Consequence To Patient	45	45
Insufficient Information	11	11
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
Perforation of Vessels	3	3
Shaking/Tremors	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
Respiratory Distress	1	1
No Code Available	1	1
No Information	1	1
Hemoptysis	1	1
Cardiac Arrest	1	1
Alteration In Body Temperature	1	1
Ventricular Fibrillation	1	1
Needle Stick/Puncture	1	1
Cardiac Perforation	1	1
Thrombosis	1	1
Reaction	1	1
Tachycardia	1	1
Swelling/ Edema	1	1
Ectopic Heartbeat	1	1
Hemothorax	1	1
Thrombus	1	1