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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
  1.  K231586  Endophys Blood Pressure Monitor model BPM-30

MDR Year MDR Reports MDR Events
2021 31 31
2022 29 29
2023 14 14
2024 12 12
2025 26 26
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 103 103
Pressure Problem 11 11
No Audible Prompt/Feedback 6 6
No Audible Alarm 4 4
Incorrect Measurement 4 4
Fracture 4 4
Low Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Unable to Obtain Readings 2 2
No Pressure 2 2
Imprecise or Erratic Results 2 2
Device Handling Problem 2 2
Increase in Pressure 2 2
Disconnection 1 1
Crack 1 1
Difficult to Flush 1 1
Device Fell 1 1
Obstruction of Flow 1 1
Insufficient Flow or Under Infusion 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
Hemorrhage/Blood Loss/Bleeding 4 4
Low Blood Pressure/ Hypotension 3 3
High Blood Pressure/ Hypertension 1 1
Exposure to Body Fluids 1 1

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