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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

MDR Year MDR Reports MDR Events
2018 93 93
2019 148 148
2020 29 29
2021 31 31
2022 29 29
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 233 233
Leak/Splash 61 61
Material Separation 24 24
Incomplete or Inadequate Connection 6 6
Fracture 4 4
Loose or Intermittent Connection 3 3
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
Device Operational Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 128 128
Blood Loss 88 88
No Clinical Signs, Symptoms or Conditions 72 72
No Known Impact Or Consequence To Patient 32 32
No Patient Involvement 17 17
Hemorrhage/Bleeding 6 6
Low Blood Pressure/ Hypotension 3 3
Tissue Damage 1 1
Air Embolism 1 1
Exposure to Body Fluids 1 1
Erosion 1 1
Thromboembolism 1 1

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