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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 HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 7 7
2016 13 13
2017 6 6
2018 93 93
2019 148 148
2020 29 29
2021 31 31
2022 29 29
2023 14 14
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 239 239
Leak/Splash 62 62
Material Separation 24 24
Device Operates Differently Than Expected 7 7
No Device Output 6 6
Incomplete or Inadequate Connection 6 6
Device Displays Incorrect Message 5 5
No Display/Image 5 5
Fracture 4 4
Loose or Intermittent Connection 3 3
Crack 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Power Up 1 1
Decrease in Pressure 1 1
Application Network Problem 1 1
Computer System Security Problem 1 1
Connection Problem 1 1
Device Operational Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Flow or Infusion 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
Reset Problem 1 1
Data Problem 1 1
Missing Test Results 1 1
Device Fell 1 1
Failure to Discharge 1 1
Display or Visual Feedback Problem 1 1
Air Leak 1 1
No Audible Alarm 1 1
Break 1 1
Detachment Of Device Component 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
No Audible Prompt/Feedback 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 135 135
Blood Loss 90 90
No Clinical Signs, Symptoms or Conditions 75 75
No Known Impact Or Consequence To Patient 39 39
No Patient Involvement 30 30
Hemorrhage/Bleeding 9 9
Low Blood Pressure/ Hypotension 3 3
Tissue Damage 1 1
High Blood Pressure/ Hypertension 1 1
Air Embolism 1 1
Exposure to Body Fluids 1 1
Erosion 1 1
Death 1 1
Thromboembolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jul-06-2012
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