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TPLC
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Device
computer, blood-pressure
Regulation Description
Blood pressure computer.
Product Code
DSK
Regulation Number
870.1110
Device Class
2
Premarket Reviews
Manufacturer
Decision
ENDOPHYS TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
93
93
2019
148
148
2020
29
29
2021
31
31
2022
29
29
2023
14
14
2024
12
12
2025
26
26
2026
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
254
254
Leak/Splash
61
61
Material Separation
24
24
Pressure Problem
12
12
Fracture
6
6
Incomplete or Inadequate Connection
6
6
No Audible Prompt/Feedback
6
6
Loose or Intermittent Connection
3
3
No Audible Alarm
3
3
Low Readings
3
3
Crack
2
2
Incorrect Measurement
2
2
No Device Output
2
2
Unable to Obtain Readings
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Difficult to Flush
1
1
Low Test Results
1
1
Use of Device Problem
1
1
Decrease in Pressure
1
1
Increase in Pressure
1
1
Disconnection
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Application Network Problem
1
1
Computer System Security Problem
1
1
Device Operational Issue
1
1
Device Contamination with Chemical or Other Material
1
1
Inadequate User Interface
1
1
Infusion or Flow Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
No Pressure
1
1
Data Problem
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
128
128
No Clinical Signs, Symptoms or Conditions
123
123
Blood Loss
88
88
No Known Impact Or Consequence To Patient
32
32
No Patient Involvement
17
17
Hemorrhage/Bleeding
7
7
Low Blood Pressure/ Hypotension
3
3
Air Embolism
1
1
High Blood Pressure/ Hypertension
1
1
Exposure to Body Fluids
1
1
Tissue Damage
1
1
Erosion
1
1
Thromboembolism
1
1
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