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	70	70
Material Rupture	24	24
Incorrect Measurement	21	21
Fluid/Blood Leak	18	18
Adverse Event Without Identified Device or Use Problem	11	11
Leak/Splash	10	10
Material Split, Cut or Torn	10	10
Appropriate Term/Code Not Available	9	9
Material Fragmentation	8	8
Material Separation	7	7
Deflation Problem	7	7
Unable to Obtain Readings	6	6
No Device Output	5	5
Difficult to Insert	5	5
Break	4	4
Detachment of Device or Device Component	4	4
Inflation Problem	3	3
Physical Resistance/Sticking	3	3
Difficult to Remove	2	2
Insufficient Information	2	2
Obstruction of Flow	2	2
Difficult or Delayed Positioning	2	2
Output Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Device Displays Incorrect Message	2	2
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
No Pressure	1	1
Material Twisted/Bent	1	1
Insufficient Flow or Under Infusion	1	1
Infusion or Flow Problem	1	1
Unintended Movement	1	1
Difficult to Advance	1	1
Material Puncture/Hole	1	1
High Test Results	1	1
Crack	1	1
Inadequacy of Device Shape and/or Size	1	1
Component Misassembled	1	1
Increase in Pressure	1	1
Failure to Advance	1	1
Protective Measures Problem	1	1
Malposition of Device	1	1
Display or Visual Feedback Problem	1	1
Deformation Due to Compressive Stress	1	1
No Display/Image	1	1
Activation, Positioning or Separation Problem	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	38	38
No Known Impact Or Consequence To Patient	17	17
Insufficient Information	12	12
Hemorrhage/Bleeding	10	10
Hypersensitivity/Allergic reaction	4	4
Foreign Body In Patient	4	4
Low Blood Pressure/ Hypotension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Perforation of Vessels	2	2
High Blood Pressure/ Hypertension	1	1
Arrhythmia	1	1
Respiratory Distress	1	1
Hemoptysis	1	1
Perforation	1	1
Blood Loss	1	1
Cardiac Arrest	1	1
Ventricular Fibrillation	1	1
Needle Stick/Puncture	1	1
Cardiac Perforation	1	1
No Patient Involvement	1	1
Thrombosis	1	1
Reaction	1	1
Swelling/ Edema	1	1
Tachycardia	1	1
Thrombus	1	1
Hemothorax	1	1