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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device computer, blood-pressure
Product CodeDSK
Regulation Number 870.1110
Device Class 2

MDR Year MDR Reports MDR Events
2017 6 6
2018 93 93
2019 148 148
2020 29 29
2021 31 31
2022 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 213 213
Leak/Splash 61 61
Material Separation 24 24
Incomplete or Inadequate Connection 6 6
No Device Output 4 4
Loose or Intermittent Connection 3 3
Device Operates Differently Than Expected 3 3
Fracture 2 2
Crack 2 2
No Display/Image 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Use of Device Problem 1 1
No Audible Prompt/Feedback 1 1
Decrease in Pressure 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 130 130
Blood Loss 88 88
No Clinical Signs, Symptoms or Conditions 51 51
No Known Impact Or Consequence To Patient 33 33
No Patient Involvement 19 19
Hemorrhage/Bleeding 7 7
Low Blood Pressure/ Hypotension 3 3
Tissue Damage 1 1
Air Embolism 1 1
Erosion 1 1
Thromboembolism 1 1

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