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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
Product CodeDSK
Regulation Number 870.1110
Device Class 2


Premarket Reviews
ManufacturerDecision
ENDOPHYS TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 148 148
2020 29 29
2021 31 31
2022 29 29
2023 14 14
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 200 200
Material Separation 22 22
Leak/Splash 7 7
Incomplete or Inadequate Connection 6 6
Fracture 3 3
Loose or Intermittent Connection 2 2
No Device Output 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Decrease in Pressure 1 1
No Audible Alarm 1 1
Crack 1 1
No Display/Image 1 1
Use of Device Problem 1 1
No Audible Prompt/Feedback 1 1
Application Network Problem 1 1
Computer System Security Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate User Interface 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Data Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 87 87
No Clinical Signs, Symptoms or Conditions 76 76
Blood Loss 44 44
No Known Impact Or Consequence To Patient 30 30
No Patient Involvement 15 15
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 3 3
Exposure to Body Fluids 1 1

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