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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, blood-pressure, extravascular
Product CodeDRS
Regulation Number 870.2850
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIT MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 84 84
2020 41 41
2021 93 93
2022 95 95
2023 152 152
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 103 103
Fluid/Blood Leak 68 68
Disconnection 58 58
Break 38 38
Incorrect, Inadequate or Imprecise Result or Readings 32 32
Separation Failure 29 29
Separation Problem 18 18
Unable to Obtain Readings 13 13
Pressure Problem 12 12
Air/Gas in Device 10 10
Incorrect Measurement 10 10
Crack 9 9
Leak/Splash 9 9
Inaccurate Information 9 9
Detachment of Device or Device Component 9 9
High Readings 7 7
Mechanical Problem 6 6
Reflux within Device 5 5
Device Markings/Labelling Problem 5 5
Device Sensing Problem 5 5
Connection Problem 5 5
Device Contamination with Chemical or Other Material 5 5
No Flow 5 5
Output Problem 4 4
Infusion or Flow Problem 4 4
Loss of or Failure to Bond 4 4
Backflow 3 3
Failure to Zero 3 3
Obstruction of Flow 3 3
Failure to Calibrate 3 3
Material Integrity Problem 3 3
Inappropriate Waveform 3 3
Difficult to Insert 3 3
Material Split, Cut or Torn 3 3
Calibration Problem 2 2
Fail-Safe Problem 2 2
Gas/Air Leak 2 2
Improper Flow or Infusion 2 2
Activation, Positioning or Separation Problem 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Loose or Intermittent Connection 2 2
Display Difficult to Read 2 2
Difficult to Flush 2 2
Fracture 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Melted 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Particulates 1 1
Device Difficult to Program or Calibrate 1 1
Display or Visual Feedback Problem 1 1
Deflation Problem 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Failure to Analyze Signal 1 1
Material Rupture 1 1
Failure to Sense 1 1
Blocked Connection 1 1
Failure to Select Signal 1 1
Device Slipped 1 1
Mechanical Jam 1 1
Material Deformation 1 1
Priming Problem 1 1
No Pressure 1 1
Unintended Movement 1 1
Component Misassembled 1 1
Explosion 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 326 326
No Consequences Or Impact To Patient 78 78
Blood Loss 23 23
No Known Impact Or Consequence To Patient 19 19
Insufficient Information 18 18
No Patient Involvement 17 17
Hemorrhage/Bleeding 12 12
Low Blood Pressure/ Hypotension 3 3
Death 3 3
Discomfort 2 2
No Information 2 2
Respiratory Insufficiency 1 1
Full thickness (Third Degree) Burn 1 1
Pneumothorax 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Air Embolism 1 1
Atrial Flutter 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Nov-05-2019
2 Edwards Lifesciences, LLC II Nov-29-2023
3 ICU Medical, Inc. II Mar-28-2019
4 Smiths Medical ASD Inc. II Apr-21-2021
5 Smiths Medical Asd Inc II Jan-17-2024
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