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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


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 68 68
2017 47 47
2018 38 38
2019 63 63
2020 39 39
2021 39 39
2022 57 57
2023 52 52
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 108 108
Material Rupture 69 69
Incorrect Measurement 40 40
Leak/Splash 35 35
Adverse Event Without Identified Device or Use Problem 25 25
Fluid/Blood Leak 19 19
Appropriate Term/Code Not Available 15 15
Deflation Problem 12 12
Difficult to Insert 12 12
Material Separation 11 11
Material Split, Cut or Torn 11 11
Inflation Problem 11 11
Output Problem 9 9
Break 9 9
Unable to Obtain Readings 8 8
Kinked 7 7
Material Fragmentation 7 7
Device Contamination with Chemical or Other Material 7 7
Detachment of Device or Device Component 6 6
Positioning Problem 5 5
Difficult to Remove 5 5
Detachment Of Device Component 4 4
Device Operates Differently Than Expected 4 4
Physical Resistance/Sticking 4 4
Difficult to Advance 3 3
Malposition of Device 3 3
Contamination /Decontamination Problem 2 2
Insufficient Flow or Under Infusion 2 2
Microbial Contamination of Device 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Obstruction of Flow 2 2
High Test Results 2 2
Low Readings 2 2
Failure to Advance 2 2
Temperature Problem 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Crack 2 2
Display or Visual Feedback Problem 2 2
Burst Container or Vessel 2 2
Device Alarm System 2 2
Increase in Pressure 2 2
Knotted 2 2
No Device Output 2 2
Unintended Movement 2 2
Insufficient Information 2 2
Component Misassembled 1 1
Failure to Deflate 1 1
Overheating of Device 1 1
Pacing Problem 1 1
Peeled/Delaminated 1 1
Looping 1 1
Material Puncture/Hole 1 1
Poor Quality Image 1 1
Retraction Problem 1 1
Backflow 1 1
Calibration Error 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
No Display/Image 1 1
False Reading From Device Non-Compliance 1 1
Inaccurate Flow Rate 1 1
Material Frayed 1 1
Hole In Material 1 1
No Pressure 1 1
Output below Specifications 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Physical Resistance 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Unstable 1 1
Failure to Zero 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Activation, Positioning or Separation Problem 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 189 189
No Clinical Signs, Symptoms or Conditions 121 121
No Known Impact Or Consequence To Patient 72 72
Hemorrhage/Bleeding 11 11
No Patient Involvement 8 8
Insufficient Information 8 8
No Code Available 7 7
No Information 5 5
Blood Loss 5 5
Cardiac Perforation 5 5
Perforation of Vessels 4 4
Hypersensitivity/Allergic reaction 4 4
Perforation 4 4
Low Blood Pressure/ Hypotension 4 4
Foreign Body In Patient 4 4
Unspecified Infection 3 4
Congenital Defect/Deformity 3 3
Shaking/Tremors 3 3
Injury 2 2
Chills 2 2
Respiratory Distress 2 2
Thrombus 2 2
Hemothorax 2 2
Fever 2 2
Hematoma 2 2
Patient Problem/Medical Problem 2 2
Cardiac Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ectopic Heartbeat 1 1
Alteration In Body Temperature 1 1
Device Embedded In Tissue or Plaque 1 1
Hemoptysis 1 1
Infiltration into Tissue 1 1
Mitral Valve Stenosis 1 1
Necrosis 1 1
Death 1 1
Dyspnea 1 1
Embolism 1 1
Encephalopathy 1 1
Angina 1 1
Aortic Insufficiency 1 1
Aortic Valve Stenosis 1 1
Arrhythmia 1 1
Tricuspid Regurgitation 1 1
Ventricular Fibrillation 1 1
Thrombosis 1 1
Pneumonia 1 1
Pneumothorax 1 1
High Blood Pressure/ Hypertension 1 1
Stenosis 1 1
Reaction 1 1
Needle Stick/Puncture 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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