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
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
Break	7	7
Inflation Problem	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
Temperature Problem	2	2
Display or Visual Feedback Problem	2	2
Difficult or Delayed Positioning	2	2
Device Contamination with Chemical or Other Material	2	2
Malposition of Device	2	2
Device Displays Incorrect Message	2	2
Defective Device	2	2
Difficult to Remove	2	2
Material Puncture/Hole	2	2
Increase in Pressure	2	2
Obstruction of Flow	2	2
Microbial Contamination of Device	2	2
Insufficient Flow or Under Infusion	2	2
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Activation, Positioning or Separation Problem	1	1
Difficult to Advance	1	1
Gas/Air Leak	1	1
Human-Device Interface Problem	1	1
Infusion or Flow Problem	1	1
Failure to Advance	1	1
Burst Container or Vessel	1	1
Crack	1	1
High Test Results	1	1
Retraction Problem	1	1
Positioning Failure	1	1
No Display/Image	1	1
Material Frayed	1	1
Material Twisted/Bent	1	1
Pacing Problem	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
No Patient Involvement	4	4
Foreign Body In Patient	4	4
Hypersensitivity/Allergic reaction	4	4
Low Blood Pressure/ Hypotension	4	4
Shaking/Tremors	3	3
Perforation of Vessels	3	3
Unspecified Infection	3	4
Perforation	2	2
Chills	2	2
Fever	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Alteration In Body Temperature	1	1
No Information	1	1
No Code Available	1	1
Reaction	1	1
Needle Stick/Puncture	1	1
Cardiac Perforation	1	1
Respiratory Distress	1	1
Tachycardia	1	1
Thrombosis	1	1
Thrombus	1	1
Ventricular Fibrillation	1	1
Arrhythmia	1	1
Cardiac Arrest	1	1
Hemoptysis	1	1
Hemothorax	1	1
High Blood Pressure/ Hypertension	1	1
Swelling/ Edema	1	1