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	87	87
Material Rupture	58	58
Incorrect Measurement	29	29
Fluid/Blood Leak	25	25
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
Break	7	7
Unable to Obtain Readings	7	7
Inflation Problem	6	6
No Device Output	5	5
Detachment of Device or Device Component	5	5
Difficult to Insert	5	5
Physical Resistance/Sticking	4	4
Output Problem	3	3
Defective Device	2	2
Insufficient Information	2	2
Difficult to Remove	2	2
Microbial Contamination of Device	2	2
Display or Visual Feedback Problem	2	2
Material Puncture/Hole	2	2
Device Displays Incorrect Message	2	2
Increase in Pressure	2	2
Obstruction of Flow	2	2
Device Contamination with Chemical or Other Material	2	2
Insufficient Flow or Under Infusion	2	2
Difficult or Delayed Positioning	2	2
Malposition of Device	2	2
Temperature Problem	2	2
Human-Device Interface Problem	1	1
Overheating of Device	1	1
Protective Measures Problem	1	1
Failure to Advance	1	1
Pacing Problem	1	1
Component Misassembled	1	1
Deformation Due to Compressive Stress	1	1
Inadequacy of Device Shape and/or Size	1	1
Output below Specifications	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
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	160	160
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