Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 52 52
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 70 70
Material Rupture 55 55
Incorrect Measurement 28 28
Fluid/Blood Leak 18 18
Adverse Event Without Identified Device or Use Problem 12 12
Leak/Splash 12 12
Material Split, Cut or Torn 11 11
Appropriate Term/Code Not Available 9 9
Deflation Problem 9 9
Material Separation 9 9
Unable to Obtain Readings 7 7
Material Fragmentation 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
Temperature Problem 2 2
Insufficient Information 2 2
Device Contamination with Chemical or Other Material 2 2
Increase in Pressure 2 2
No Device Output 2 2
Display or Visual Feedback Problem 2 2
Difficult to Remove 2 2
Insufficient Flow or Under Infusion 2 2
Microbial Contamination of Device 2 2
Obstruction of Flow 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Malposition of Device 2 2
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
High Test Results 1 1
Failure to Advance 1 1
Retraction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unstable 1 1
Material Frayed 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
No Display/Image 1 1
Overheating of Device 1 1
Pacing Problem 1 1
Material Puncture/Hole 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Difficult to Advance 1 1
No Pressure 1 1
Output below Specifications 1 1
Component Misassembled 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Failure to Deflate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 121 121
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 45 45
Hemorrhage/Bleeding 10 10
Insufficient Information 8 8
Blood Loss 5 5
No Patient Involvement 4 4
Foreign Body In Patient 4 4
Hypersensitivity/Allergic reaction 4 4
Perforation of Vessels 3 3
Low Blood Pressure/ Hypotension 3 3
Unspecified Infection 3 4
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
Reaction 1 1
Needle Stick/Puncture 1 1
Cardiac Perforation 1 1
Hemoptysis 1 1
Hemothorax 1 1
Respiratory Distress 1 1
Thrombosis 1 1
Thrombus 1 1
Ventricular Fibrillation 1 1
Alteration In Body Temperature 1 1
No Information 1 1
No Code Available 1 1
Ectopic Heartbeat 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
-
-