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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 87 88
Material Rupture 28 28
Fluid/Blood Leak 27 27
Incorrect Measurement 25 25
Adverse Event Without Identified Device or Use Problem 11 11
Leak/Splash 9 9
Appropriate Device Problem Term/Code Not Available 9 9
Material Split, Cut or Torn 8 8
Material Fragmentation 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
Difficult to Remove 3 3
Obstruction of Flow 3 3
Detachment of Device or Device Component 3 3
Material Puncture/Hole 2 2
Insufficient Device Problem Information 2 2
Difficult or Delayed Positioning 2 2
Inflation Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Activation, Positioning or Separation Problem 1 1
Burst Container or Vessel 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Unintended Movement 1 2
Positioning Problem 1 1
High Readings 1 1
Air/Gas in Device 1 1
No Pressure 1 1
Insufficient Flow or Under Infusion 1 1
Infusion or Flow Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 194 195
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 12 12
Hypersensitivity/Allergic reaction 4 4
Foreign Body In Patient 4 4
Low Blood Pressure/ Hypotension 4 4
Perforation of Vessels 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 3
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
Thrombosis 1 1
No Patient Involvement 1 1
Reaction 1 1
Tachycardia 1 1
Hemothorax 1 1
Thrombus 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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