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	121	121
Material Rupture	76	76
Leak/Splash	50	50
Incorrect Measurement	44	44
Appropriate Term/Code Not Available	34	34
Adverse Event Without Identified Device or Use Problem	33	33
Fluid/Blood Leak	20	20
Device Contamination with Chemical or Other Material	19	19
Deflation Problem	17	17
Unable to Obtain Readings	13	13
Inflation Problem	12	12
Difficult to Insert	12	12
Material Split, Cut or Torn	12	12
Material Separation	11	11
Break	9	9
Output Problem	9	9
Material Fragmentation	8	8
Kinked	7	7
Detachment of Device or Device Component	6	6
Device Operates Differently Than Expected	6	6
Detachment Of Device Component	6	6
Positioning Problem	5	5
Difficult to Remove	5	5
Material Puncture/Hole	5	5
Difficult to Advance	4	4
Physical Resistance/Sticking	4	4
Low Readings	3	3
Malposition of Device	3	3
No Device Output	3	3
Crack	3	3
Difficult or Delayed Positioning	2	2
High Test Results	2	2
Burst Container or Vessel	2	2
Unintended Movement	2	2
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Microbial Contamination of Device	2	2
Obstruction of Flow	2	2
Component Missing	2	2
Material Twisted/Bent	2	2
Insufficient Flow or Under Infusion	2	2
Material Protrusion/Extrusion	2	2
Knotted	2	2
Material Integrity Problem	2	2
Failure to Advance	2	2
Defective Device	2	2
Device Alarm System	2	2
Torn Material	2	2
Increase in Pressure	2	2
Temperature Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	265	265
No Clinical Signs, Symptoms or Conditions	134	134
No Known Impact Or Consequence To Patient	76	76
Hemorrhage/Bleeding	13	13
Insufficient Information	11	11
No Code Available	9	9
No Information	8	8
No Patient Involvement	8	8
Cardiac Perforation	7	7
Low Blood Pressure/ Hypotension	6	6
Blood Loss	6	6
Perforation of Vessels	5	5
Hypersensitivity/Allergic reaction	4	4
Perforation	4	4
Foreign Body In Patient	4	4
Cardiac Arrest	4	4
Unspecified Infection	3	4
Shaking/Tremors	3	3
Arrhythmia	3	3
Congenital Defect/Deformity	3	3
Hemothorax	2	2
Thrombus	2	2
Aneurysm	2	2
Chills	2	2
Fever	2	2
Injury	2	2
Hematoma	2	2
Respiratory Distress	2	2
Pneumothorax	2	2
Death	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	2	2
Alteration In Body Temperature	1	1
Angina	1	1
Rupture	1	1
Complete Heart Block	1	1
Hemoptysis	1	1
Ventricular Fibrillation	1	1
Needle Stick/Puncture	1	1
Therapy/non-surgical treatment/delayed/prolonged	1	1
Necrosis	1	1
Thrombosis	1	1
Ventricular Tachycardia	1	1
Dyspnea	1	1
Pneumonia	1	1
Reaction	1	1
Aortic Insufficiency	1	1
Stenosis	1	1
Swelling/ Edema	1	1
Tachycardia	1	1