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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, oximeter, fiber-optic
Regulation Description Fiberoptic oximeter catheter.
Product CodeDQE
Regulation Number 870.1230
Device Class 2

MDR Year MDR Reports MDR Events
2020 39 39
2021 39 39
2022 57 57
2023 48 50
2024 47 47
2025 31 31
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 85 86
Material Rupture 28 28
Fluid/Blood Leak 27 27
Incorrect Measurement 25 25
Adverse Event Without Identified Device or Use Problem 10 10
Appropriate Device Problem Term/Code Not Available 9 9
Leak/Splash 9 9
Material Fragmentation 8 8
Material Split, Cut or Torn 8 8
Material Separation 7 7
Deflation Problem 6 6
Unable to Obtain Readings 6 7
Difficult to Insert 5 5
Break 4 4
No Device Output 4 4
Detachment of Device or Device Component 3 3
Difficult to Remove 3 3
Obstruction of Flow 3 3
Difficult or Delayed Positioning 2 2
Inflation Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Insufficient Device Problem Information 2 2
Material Puncture/Hole 2 2
Burst Container or Vessel 1 1
Crack 1 1
Activation, Positioning or Separation Problem 1 1
Infusion or Flow Problem 1 1
No Pressure 1 1
Positioning Problem 1 1
Unintended Movement 1 2
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Inadequacy of Device Shape and/or Size 1 1
Air/Gas in Device 1 1
Insufficient Flow or Under Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 190 191
No Consequences Or Impact To Patient 38 38
No Known Impact Or Consequence To Patient 17 17
Insufficient Information 13 13
Hemorrhage/Blood Loss/Bleeding 11 11
Foreign Body In Patient 4 4
Hypersensitivity/Allergic reaction 4 4
Low Blood Pressure/ Hypotension 4 4
Perforation of Vessels 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 3
Thrombosis 1 1
Cardiac Arrest 1 1
Hemothorax 1 1
Swelling/ Edema 1 1
Arrhythmia 1 1
High Blood Pressure/ Hypertension 1 1
Respiratory Distress 1 1
Ventricular Fibrillation 1 1
Hemoptysis 1 1
Perforation 1 1
Tachycardia 1 1
Needle Stick/Puncture 1 1
Reaction 1 1
Thrombus 1 1
Cardiac Perforation 1 1
Blood Loss 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Aug-12-2021
2 Edwards Lifesciences, LLC II Jul-10-2020
3 ICU Medical, Inc. II May-14-2020
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