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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
71
71
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unable to Obtain Readings
33
33
Leak/Splash
17
17
Fluid/Blood Leak
16
16
Incorrect, Inadequate or Imprecise Result or Readings
15
15
Failure to Calibrate
12
12
Data Problem
12
12
Display or Visual Feedback Problem
11
11
Failure to Sense
9
9
Failure to Zero
8
8
Detachment of Device or Device Component
8
8
Loose or Intermittent Connection
8
8
Air/Gas in Device
8
8
No Display/Image
7
7
Disconnection
6
6
Tear, Rip or Hole in Device Packaging
6
6
Connection Problem
6
6
Device Sensing Problem
5
5
Break
5
5
Fracture
5
5
Inappropriate Waveform
4
4
Defective Device
4
4
Difficult to Open or Close
3
3
Mechanical Problem
3
3
Erratic Results
3
3
Material Deformation
3
3
Pressure Problem
2
2
Insufficient Information
2
2
No Device Output
2
2
Failure to Recalibrate
2
2
Crack
2
2
Backflow
2
2
Gas/Air Leak
2
2
Calibration Problem
2
2
Obstruction of Flow
2
2
Defective Component
2
2
Improper or Incorrect Procedure or Method
1
1
Device Damaged Prior to Use
1
1
Material Separation
1
1
High Sensing Threshold
1
1
Device Alarm System
1
1
Flushing Problem
1
1
Excess Flow or Over-Infusion
1
1
Decrease in Pressure
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
133
133
Insufficient Information
18
18
No Patient Involvement
5
5
No Consequences Or Impact To Patient
2
2
Perforation of Esophagus
2
2
Ischemic Heart Disease
1
1
No Known Impact Or Consequence To Patient
1
1
Valvular Insufficiency/ Regurgitation
1
1
Bradycardia
1
1
Death
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Skin Erosion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, LLC
II
Sep-18-2015
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