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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
2020 29 29
2021 31 31
2022 29 29
2023 14 14
2024 12 12
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 104 104
Pressure Problem 8 8
Fracture 4 4
Leak/Splash 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Unable to Obtain Readings 2 2
Loose or Intermittent Connection 2 2
Disconnection 1 1
Crack 1 1
Device Fell 1 1
No Audible Alarm 1 1
Decrease in Pressure 1 1
No Audible Prompt/Feedback 1 1
Material Separation 1 1
Application Network Problem 1 1
Computer System Security Problem 1 1
Display or Visual Feedback Problem 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 98 98
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 10 10
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 2 2
High Blood Pressure/ Hypertension 1 1
Exposure to Body Fluids 1 1
No Patient Involvement 1 1

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