TPLC - Total Product Life Cycle

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Device	catheter, oximeter, fiber-optic
Regulation Description	Fiberoptic oximeter catheter.
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	84	84
Material Rupture	55	55
Incorrect Measurement	29	29
Fluid/Blood Leak	24	24
Adverse Event Without Identified Device or Use Problem	16	16
Leak/Splash	13	13
Material Split, Cut or Torn	11	11
Appropriate Term/Code Not Available	9	9
Deflation Problem	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
Display or Visual Feedback Problem	2	2
Insufficient Information	2	2
Defective Device	2	2
Device Displays Incorrect Message	2	2
Difficult to Remove	2	2
Material Puncture/Hole	2	2
Microbial Contamination of Device	2	2
Obstruction of Flow	2	2
Increase in Pressure	2	2
Insufficient Flow or Under Infusion	2	2
Malposition of Device	2	2
Difficult or Delayed Positioning	2	2
Device Contamination with Chemical or Other Material	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	150	150
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
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
Hemothorax	1	1
Thrombus	1	1