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
Leak/Splash	12	12
Material Split, Cut or Torn	12	12
Deflation Problem	9	9
Appropriate Term/Code Not Available	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
Microbial Contamination of Device	2	2
Difficult to Remove	2	2
Difficult or Delayed Positioning	2	2
No Device Output	2	2
Temperature Problem	2	2
Increase in Pressure	2	2
Insufficient Flow or Under Infusion	2	2
Device Contamination with Chemical or Other Material	2	2
Obstruction of Flow	2	2
Display or Visual Feedback Problem	2	2
Insufficient Information	2	2
Device Displays Incorrect Message	2	2
Malposition of Device	2	2
Defective Device	2	2
Retraction Problem	1	1
Component Misassembled	1	1
Inadequacy of Device Shape and/or Size	1	1
High Test Results	1	1
Human-Device Interface Problem	1	1
Failure to Deflate	1	1
Deformation Due to Compressive Stress	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Contamination /Decontamination Problem	1	1
Output below Specifications	1	1
Overheating of Device	1	1
Pacing Problem	1	1
Protective Measures Problem	1	1
Failure to Advance	1	1
Infusion or Flow Problem	1	1
Material Twisted/Bent	1	1
Gas/Air Leak	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