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TPLC
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Device
catheter, oximeter, fiber-optic
Product Code
DQE
Regulation Number
870.1230
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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