Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 203 203
Material Separation 22 22
Leak/Splash 7 7
Incomplete or Inadequate Connection 6 6
Fracture 3 3
Crack 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Loose or Intermittent Connection 2 2
No Device Output 2 2
Application Network Problem 1 1
Pressure Problem 1 1
No Display/Image 1 1
Device Fell 1 1
No Audible Alarm 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Decrease in Pressure 1 1
No Audible Prompt/Feedback 1 1
Data Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Computer System Security Problem 1 1
Use of Device Problem 1 1
Inadequate User Interface 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 79 79
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

-
-