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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
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 38 38
2015 58 58
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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 113 113
Material Rupture 76 76
Leak/Splash 50 50
Incorrect Measurement 42 42
Appropriate Term/Code Not Available 32 32
Adverse Event Without Identified Device or Use Problem 28 28
Device Contamination with Chemical or Other Material 19 19
Fluid/Blood Leak 18 18
Deflation Problem 17 17
Unable to Obtain Readings 13 13
Inflation Problem 12 12
Difficult to Insert 12 12
Material Separation 11 11
Material Split, Cut or Torn 11 11
Output Problem 9 9
Break 9 9
Material Fragmentation 7 7
Kinked 7 7
Detachment Of Device Component 6 6
Detachment of Device or Device Component 6 6
Device Operates Differently Than Expected 6 6
Difficult to Remove 5 5
Material Puncture/Hole 5 5
Positioning Problem 5 5
Physical Resistance/Sticking 4 4
Difficult to Advance 4 4
Low Readings 3 3
Malposition of Device 3 3
No Device Output 3 3
Crack 3 3
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
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Failure to Advance 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Insufficient Flow or Under Infusion 2 2
Microbial Contamination of Device 2 2
Component Missing 2 2
High Test Results 2 2
Torn Material 2 2
Unintended Movement 2 2
Insufficient Information 2 2
Temperature Problem 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
No Pressure 1 1
Output below Specifications 1 1
Therapeutic or Diagnostic Output Failure 1 1
Protective Measures Problem 1 1
Component Misassembled 1 1
Failure to Deflate 1 1
High Readings 1 1
Obstruction of Flow 1 1
Defective Component 1 1
Retraction Problem 1 1
Shelf Life Exceeded 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Unstable 1 1
Use of Device Problem 1 1
Failure to Zero 1 1
Improper or Incorrect Procedure or Method 1 1
Physical Resistance 1 1
Activation, Positioning or Separation Problem 1 1
Deformation Due to Compressive Stress 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
Poor Quality Image 1 1
Occlusion Within Device 1 1
Looping 1 1
Overheating of Device 1 1
Pacing Problem 1 1
Peeled/Delaminated 1 1
Difficult To Position 1 1
Signal Artifact/Noise 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
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 265 265
No Clinical Signs, Symptoms or Conditions 119 119
No Known Impact Or Consequence To Patient 76 76
Hemorrhage/Bleeding 11 11
No Code Available 9 9
Insufficient Information 8 8
No Information 8 8
No Patient Involvement 8 8
Cardiac Perforation 7 7
Blood Loss 6 6
Foreign Body In Patient 4 4
Low Blood Pressure/ Hypotension 4 4
Hypersensitivity/Allergic reaction 4 4
Perforation 4 4
Perforation of Vessels 3 3
Unspecified Infection 3 4
Cardiac Arrest 3 3
Congenital Defect/Deformity 3 3
Shaking/Tremors 3 3
Injury 2 2
Patient Problem/Medical Problem 2 2
Arrhythmia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Death 2 2
Aneurysm 2 2
Hemothorax 2 2
Fever 2 2
Hematoma 2 2
Chills 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
Thrombus 2 2
Tricuspid Regurgitation 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Pneumonia 1 1
High Blood Pressure/ Hypertension 1 1
Thrombosis 1 1
Rupture 1 1
Stenosis 1 1
Complaint, Ill-Defined 1 1
Hemoptysis 1 1
Infiltration into Tissue 1 1
Mitral Valve Stenosis 1 1
Necrosis 1 1
Angina 1 1
Aortic Insufficiency 1 1
Aortic Valve Stenosis 1 1
Dyspnea 1 1
Embolism 1 1
Encephalopathy 1 1
Ectopic Heartbeat 1 1
Device Embedded In Tissue or Plaque 1 1
Alteration In Body Temperature 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Therapy/non-surgical treatment/delayed/prolonged 1 1
Complete Heart Block 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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