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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
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
251
251
Leak/Splash
61
61
Material Separation
24
24
Pressure Problem
10
10
Incomplete or Inadequate Connection
6
6
Fracture
5
5
No Audible Prompt/Feedback
4
4
No Audible Alarm
3
3
Low Readings
3
3
Loose or Intermittent Connection
3
3
Crack
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Unable to Obtain Readings
2
2
Incorrect Measurement
2
2
No Device Output
2
2
Disconnection
1
1
No Display/Image
1
1
Device Operational Issue
1
1
Difficult to Flush
1
1
Device Fell
1
1
Use of Device Problem
1
1
Decrease in Pressure
1
1
Infusion or Flow Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Data Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Increase in Pressure
1
1
Application Network Problem
1
1
Computer System Security Problem
1
1
Display or Visual Feedback Problem
1
1
Low Test Results
1
1
Inadequate User Interface
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
115
115
Blood Loss
88
88
No Known Impact Or Consequence To Patient
32
32
No Patient Involvement
17
17
Hemorrhage/Bleeding
6
6
Low Blood Pressure/ Hypotension
3
3
Tissue Damage
1
1
High Blood Pressure/ Hypertension
1
1
Air Embolism
1
1
Exposure to Body Fluids
1
1
Erosion
1
1
Thromboembolism
1
1
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