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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-invasive central venous manometer
Regulation Description Venous blood pressure manometer.
Definition Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
Product CodePFA
Regulation Number 870.1140
Device Class 2

MDR Year MDR Reports MDR Events
2024 28 28
2025 3 3
2026 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 25 25
Material Twisted/Bent 7 7
Improper or Incorrect Procedure or Method 6 6
Complete Blockage 3 3
Infusion or Flow Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Detachment of Device or Device Component 3 3
Fluid/Blood Leak 3 3
Biocompatibility 2 2
Leak/Splash 1 1
Use of Incorrect Control/Treatment Settings 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Hyperglycemia 17 17
Elevated ketones/Diabetic Ketoacidosis 8 8
Unspecified Infection 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Headache 1 1

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