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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
2021 31 31
2022 29 29
2023 14 14
2024 12 12
2025 26 26
2026 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 97 97
Pressure Problem 11 11
No Audible Prompt/Feedback 6 6
Fracture 4 4
No Audible Alarm 4 4
Low Readings 3 3
Incorrect Measurement 3 3
Unable to Obtain Readings 2 2
Increase in Pressure 2 2
No Pressure 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Low Test Results 1 1
Device Fell 1 1
Crack 1 1
Difficult to Flush 1 1
Imprecise or Erratic Results 1 1
Application Network Problem 1 1
Insufficient Flow or Under Infusion 1 1
Display or Visual Feedback Problem 1 1
Computer System Security Problem 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 131
Hemorrhage/Blood Loss/Bleeding 4 4
Low Blood Pressure/ Hypotension 3 3
Exposure to Body Fluids 1 1
High Blood Pressure/ Hypertension 1 1

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