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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

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 86 86
Pressure Problem 9 9
No Audible Prompt/Feedback 4 4
No Audible Alarm 3 3
Fracture 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Unable to Obtain Readings 2 2
Disconnection 1 1
Crack 1 1
Difficult to Flush 1 1
Device Fell 1 1
Incorrect Measurement 1 1
Low Readings 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 107 107
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 2 2
High Blood Pressure/ Hypertension 1 1
Exposure to Body Fluids 1 1

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