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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 probe, blood-flow, extravascular
Product CodeDPT
Regulation Number 870.2120
Device Class 2


Premarket Reviews
ManufacturerDecision
RWD LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 3 3
2021 13 13
2022 46 46
2023 21 21
2024 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 34 34
Leak/Splash 19 19
Fluid/Blood Leak 16 16
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Failure to Calibrate 14 14
Data Problem 12 12
Display or Visual Feedback Problem 11 11
Failure to Sense 9 9
Failure to Zero 9 9
Device Sensing Problem 8 8
No Display/Image 8 8
Loose or Intermittent Connection 8 8
Air/Gas in Device 8 8
Disconnection 6 6
Connection Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Break 5 5
Fracture 5 5
Inappropriate Waveform 4 4
Defective Device 4 4
Calibration Problem 4 4
Detachment of Device or Device Component 3 3
Difficult to Open or Close 3 3
Mechanical Problem 3 3
Erratic Results 3 3
Material Deformation 3 3
Pressure Problem 3 3
No Device Output 2 2
Failure to Recalibrate 2 2
Crack 2 2
Backflow 2 2
Gas/Air Leak 2 2
Obstruction of Flow 2 2
Defective Component 2 2
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Material Separation 1 1
High Sensing Threshold 1 1
Device Alarm System 1 1
Flushing Problem 1 1
Excess Flow or Over-Infusion 1 1
Decrease in Pressure 1 1
Increase in Pressure 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 144 144
Insufficient Information 18 18
No Consequences Or Impact To Patient 2 2
Ischemic Heart Disease 1 1
No Known Impact Or Consequence To Patient 1 1
Valvular Insufficiency/ Regurgitation 1 1
Bradycardia 1 1
Death 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1

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