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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
Product CodeDQE
Regulation Number 870.1230
Device Class 2

MDR Year MDR Reports MDR Events
2019 63 63
2020 39 39
2021 39 39
2022 57 57
2023 53 53
2024 32 32

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

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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