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TPLC
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show TPLC since
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Device
computer, blood-pressure
Product Code
DSK
Regulation Number
870.1110
Device Class
2
Premarket Reviews
Manufacturer
Decision
ENDOPHYS HOLDINGS, LLC
SUBSTANTIALLY EQUIVALENT
1
ENDOPHYS TECHNOLOGIES LLC
SUBSTANTIALLY EQUIVALENT
1
ENDOPHYS, INC.
SUBSTANTIALLY EQUIVALENT
1
VOLCANO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
7
7
2016
13
13
2017
6
6
2018
93
93
2019
148
148
2020
29
29
2021
31
31
2022
29
29
2023
14
14
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
243
243
Leak/Splash
62
62
Material Separation
24
24
Device Operates Differently Than Expected
7
7
Incomplete or Inadequate Connection
6
6
No Device Output
6
6
No Display/Image
5
5
Device Displays Incorrect Message
5
5
Fracture
4
4
Crack
3
3
Loose or Intermittent Connection
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Air Leak
1
1
No Audible Prompt/Feedback
1
1
Data Problem
1
1
Reset Problem
1
1
Pressure Problem
1
1
Break
1
1
Device Operational Issue
1
1
Device Fell
1
1
Use of Device Problem
1
1
Improper Flow or Infusion
1
1
Failure to Power Up
1
1
Decrease in Pressure
1
1
Missing Test Results
1
1
Infusion or Flow Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Display or Visual Feedback Problem
1
1
No Audible Alarm
1
1
Connection Problem
1
1
Application Network Problem
1
1
Computer System Security Problem
1
1
Device Inoperable
1
1
Inadequate User Interface
1
1
Failure to Discharge
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
135
135
Blood Loss
90
90
No Clinical Signs, Symptoms or Conditions
79
79
No Known Impact Or Consequence To Patient
39
39
No Patient Involvement
30
30
Hemorrhage/Bleeding
9
9
Low Blood Pressure/ Hypotension
3
3
Air Embolism
1
1
High Blood Pressure/ Hypertension
1
1
Death
1
1
Exposure to Body Fluids
1
1
Tissue Damage
1
1
Erosion
1
1
Thromboembolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Argon Medical Devices, Inc
II
Jul-06-2012
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