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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 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 70 70
Material Rupture 61 61
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
Kinked 7 7
Fluid Leak 7 7
Appropriate Term/Code Not Available 7 7
Device Contamination with Chemical or Other Material 7 7
Break 6 6
Material Separation 6 6
Detachment Of Device Component 4 4
Material Split, Cut or Torn 4 4
Positioning Problem 4 4
Device Operates Differently Than Expected 4 4
Difficult to Advance 3 3
Detachment of Device or Device Component 3 3
Malposition of Device 3 3
Unable to Obtain Readings 3 3
Difficult to Remove 3 3
Increase in Pressure 2 2
Insufficient Flow or Under Infusion 2 2
Microbial Contamination of Device 2 2
Crack 2 2
Burst Container or Vessel 2 2
Device Alarm System 2 2
Display or Visual Feedback Problem 2 2
Knotted 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
High Test Results 2 2
Low Readings 2 2
Failure to Advance 2 2
Insufficient Information 2 2
Temperature Problem 2 2
Physical Resistance/Sticking 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
No Pressure 1 1
Output below Specifications 1 1
Component Misassembled 1 1
Torn Material 1 1
Unintended Movement 1 1
Physical Resistance 1 1
Retraction Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Deformation Due to Compressive Stress 1 1
Gas Leak 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Looping 1 1
False Reading From Device Non-Compliance 1 1
Inaccurate Flow Rate 1 1
Material Frayed 1 1
Hole In Material 1 1
Backflow 1 1
Calibration Error 1 1
Positioning Failure 1 1
No Display/Image 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Device Inoperable 1 1
Unstable 1 1
Failure to Zero 1 1
Improper or Incorrect Procedure or Method 1 1
Poor Quality Image 1 1
No Device Output 1 1
Overheating of Device 1 1
Pacing Problem 1 1
Peeled/Delaminated 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 23 23
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
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1
Alteration In Body Temperature 1 1
Foreign Body In Patient 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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