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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device computer, blood-pressure
Regulation Description Blood pressure computer.
Product CodeDSK
Regulation Number 870.1110
Device Class 2


Premarket Reviews
ManufacturerDecision
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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