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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


Premarket Reviews
ManufacturerDecision
AIMAGO SA
  SUBSTANTIALLY EQUIVALENT 2
DELTEX MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MOOR INSTRUMENTS LTD
  SUBSTANTIALLY EQUIVALENT 1
MOOR INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 2
PERIMED AB
  SUBSTANTIALLY EQUIVALENT 1
SPECTRAL MD, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRALMD, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2018 3 3
2019 1 1
2020 3 3
2021 13 13
2022 46 46
2023 21 21
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 26 26
Leak/Splash 17 17
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Fluid/Blood Leak 14 14
Data Problem 12 12
Air/Gas in Device 8 8
Loose or Intermittent Connection 8 8
Failure to Sense 8 8
Detachment of Device or Device Component 8 8
Failure to Calibrate 7 7
No Display/Image 7 7
Display or Visual Feedback Problem 7 7
Disconnection 6 6
Tear, Rip or Hole in Device Packaging 6 6
Connection Problem 6 6
Failure to Zero 5 5
Device Sensing Problem 5 5
Break 5 5
Fracture 5 5
Inappropriate Waveform 4 4
Defective Device 4 4
Difficult to Open or Close 3 3
Mechanical Problem 3 3
Erratic Results 3 3
Material Deformation 3 3
Pressure Problem 2 2
Insufficient Information 2 2
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
Calibration Problem 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
Adverse Event Without Identified Device or Use Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 119
Insufficient Information 18 18
No Patient Involvement 5 5
No Consequences Or Impact To Patient 2 2
Perforation of Esophagus 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
Skin Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Sep-18-2015
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