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
Appropriate Term/Code Not Available	9	9
Material Separation	9	9
Deflation Problem	9	9
Material Fragmentation	8	8
Unable to Obtain Readings	7	7
Break	6	6
Inflation Problem	6	6
Difficult to Insert	5	5
Detachment of Device or Device Component	5	5
Physical Resistance/Sticking	4	4
Output Problem	3	3
Increase in Pressure	2	2
Insufficient Flow or Under Infusion	2	2
Obstruction of Flow	2	2
Microbial Contamination of Device	2	2
Difficult to Remove	2	2
Temperature Problem	2	2
Device Displays Incorrect Message	2	2
Display or Visual Feedback Problem	2	2
No Device Output	2	2
Difficult or Delayed Positioning	2	2
Defective Device	2	2
Device Contamination with Chemical or Other Material	2	2
Insufficient Information	2	2
Malposition of Device	2	2
Overheating of Device	1	1
Output below Specifications	1	1
Human-Device Interface Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Failure to Deflate	1	1
Failure to Advance	1	1
Pacing Problem	1	1
Protective Measures Problem	1	1
Component Misassembled	1	1
Retraction Problem	1	1
Infusion or Flow Problem	1	1
Positioning Failure	1	1
Material Twisted/Bent	1	1
Gas/Air Leak	1	1
No Pressure	1	1
Contamination /Decontamination Problem	1	1
Unstable	1	1
Material Frayed	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