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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, blood-flow, extravascular
Product CodeDPT
Regulation Number 870.2120
Device Class 2

MDR Year MDR Reports MDR Events
2018 3 3
2019 1 1
2020 3 3
2021 13 13
2022 46 46
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 16 16
Fluid/Blood Leak 10 10
Air/Gas in Device 8 8
Loose or Intermittent Connection 7 7
Disconnection 6 6
Unable to Obtain Readings 4 4
Connection Problem 4 4
Device Sensing Problem 4 4
Detachment of Device or Device Component 3 3
Data Problem 3 3
Defective Component 2 2
Pressure Problem 2 2
Insufficient Information 2 2
Mechanical Problem 2 2
No Display/Image 2 2
Break 2 2
Crack 2 2
Flushing Problem 1 1
Fracture 1 1
Excess Flow or Over-Infusion 1 1
Decrease in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Sense 1 1
Material Separation 1 1
Gas/Air Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Obstruction of Flow 1 1
High Sensing Threshold 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
Insufficient Information 10 10
No Consequences Or Impact To Patient 2 2
Perforation of Esophagus 2 2
No Known Impact Or Consequence To Patient 1 1
Bradycardia 1 1
Death 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Skin Erosion 1 1

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