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TPLC
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Device
probe, blood-flow, extravascular
Product Code
DPT
Regulation Number
870.2120
Device Class
2
Premarket Reviews
Manufacturer
Decision
AIMAGO SA
SUBSTANTIALLY EQUIVALENT
2
DELTEX MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
2
MOOR INSTRUMENTS LTD
SUBSTANTIALLY EQUIVALENT
1
MOOR INSTRUMENTS LTD.
SUBSTANTIALLY EQUIVALENT
2
PERIMED AB
SUBSTANTIALLY EQUIVALENT
1
RWD LIFE SCIENCE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SPECTRAL MD, INC
SUBSTANTIALLY EQUIVALENT
1
SPECTRALMD, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2018
3
3
2019
1
1
2020
3
3
2021
13
13
2022
46
46
2023
21
21
2024
94
94
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unable to Obtain Readings
35
35
Leak/Splash
19
19
Incorrect, Inadequate or Imprecise Result or Readings
18
18
Fluid/Blood Leak
17
17
Failure to Calibrate
16
16
Display or Visual Feedback Problem
13
13
Data Problem
12
12
Failure to Zero
9
9
Failure to Sense
9
9
No Display/Image
9
9
Air/Gas in Device
8
8
Detachment of Device or Device Component
8
8
Device Sensing Problem
8
8
Loose or Intermittent Connection
8
8
Disconnection
6
6
Tear, Rip or Hole in Device Packaging
6
6
Connection Problem
6
6
Gas/Air Leak
5
5
Break
5
5
Fracture
5
5
Defective Device
4
4
Inappropriate Waveform
4
4
Calibration Problem
4
4
Erratic Results
3
3
Mechanical Problem
3
3
Material Deformation
3
3
Difficult to Open or Close
3
3
Pressure Problem
3
3
No Device Output
2
2
Crack
2
2
Insufficient Information
2
2
Defective Component
2
2
Backflow
2
2
Obstruction of Flow
2
2
Failure to Recalibrate
2
2
Improper or Incorrect Procedure or Method
1
1
High Sensing Threshold
1
1
Flushing Problem
1
1
Inaccurate Information
1
1
Increase in Pressure
1
1
Material Separation
1
1
Decrease in Pressure
1
1
Device Alarm System
1
1
Device Damaged Prior to Use
1
1
Excess Flow or Over-Infusion
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
156
156
Insufficient Information
18
18
No Patient Involvement
5
5
Perforation of Esophagus
2
2
No Consequences Or Impact To Patient
2
2
Death
1
1
Ischemic Heart Disease
1
1
Valvular Insufficiency/ Regurgitation
1
1
No Known Impact Or Consequence To Patient
1
1
Skin Erosion
1
1
Bradycardia
1
1
Hypoxia
1
1
Low Blood Pressure/ Hypotension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, LLC
II
Sep-18-2015
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