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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


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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 70 70
Material Rupture 59 59
Leak/Splash 32 32
Incorrect Measurement 25 25
Adverse Event Without Identified Device or Use Problem 20 20
Difficult to Insert 10 10
Inflation Problem 9 9
Output Problem 9 9
Deflation Problem 8 8
Fluid Leak 7 7
Appropriate Term/Code Not Available 7 7
Kinked 7 7
Device Contamination with Chemical or Other Material 7 7
Material Separation 6 6
Break 5 5
Positioning Problem 4 4
Detachment Of Device Component 4 4
Material Split, Cut or Torn 4 4
Device Operates Differently Than Expected 4 4
Difficult to Remove 3 3
Detachment of Device or Device Component 3 3
Unable to Obtain Readings 3 3
Difficult to Advance 3 3
Malposition of Device 3 3
Contamination /Decontamination Problem 2 2
Material Integrity Problem 2 2
Insufficient Flow or Under Infusion 2 2
High Test Results 2 2
Low Readings 2 2
Failure to Advance 2 2
Device Displays Incorrect Message 2 2
Physical Resistance/Sticking 2 2
Burst Container or Vessel 2 2
Crack 2 2
Increase in Pressure 2 2
Knotted 2 2
Device Alarm System 2 2
Defective Device 2 2
Insufficient Information 2 2
Temperature Problem 2 2
Microbial Contamination of Device 2 2
Display or Visual Feedback Problem 2 2
False Reading From Device Non-Compliance 1 1
Positioning Failure 1 1
No Display/Image 1 1
Hole In Material 1 1
Looping 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Physical Resistance 1 1
No Device Output 1 1
Overheating of Device 1 1
Retraction Problem 1 1
Torn Material 1 1
Protective Measures Problem 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or SeparationProblem 1 1
Device Dislodged or Dislocated 1 1
Gas Leak 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Backflow 1 1
Calibration Error 1 1
Inaccurate Flow Rate 1 1
Material Frayed 1 1
Poor Quality Image 1 1
Pacing Problem 1 1
Peeled/Delaminated 1 1
Device Inoperable 1 1
Unstable 1 1
Failure to Zero 1 1
Improper or Incorrect Procedure or Method 1 1
Unintended Movement 1 1
Component Misassembled 1 1
No Pressure 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 189 189
No Known Impact Or Consequence To Patient 72 72
No Clinical Signs, Symptoms or Conditions 21 21
No Patient Involvement 8 8
No Code Available 7 7
Blood Loss 5 5
No Information 5 5
Cardiac Perforation 4 4
Shaking/Tremors 3 3
Perforation 3 3
Congenital Defect/Deformity 3 3
Unspecified Infection 3 4
Fever 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Cardiac Arrest 2 2
Low Blood Pressure/ Hypotension 2 2
Respiratory Distress 2 2
Thrombus 2 2
Injury 2 2
Perforation of Vessels 2 2
Chills 2 2
Patient Problem/Medical Problem 2 2
Alteration In Body Temperature 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1
Stenosis 1 1
Reaction 1 1
Tricuspid Regurgitation 1 1
Ventricular Fibrillation 1 1
Thrombosis 1 1
Pneumonia 1 1
Pneumothorax 1 1
Hemothorax 1 1
High Blood Pressure/ Hypertension 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

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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