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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 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 113 113
Fluid/Blood Leak 96 96
Disconnection 70 70
Break 55 55
Incorrect, Inadequate or Imprecise Result or Readings 36 36
Separation Failure 29 29
Separation Problem 23 23
Detachment of Device or Device Component 13 13
Unable to Obtain Readings 13 13
Pressure Problem 12 12
Crack 11 11
Incorrect Measurement 10 10
Inaccurate Information 10 10
Air/Gas in Device 10 10
Leak/Splash 9 9
High Readings 8 8
No Flow 7 7
Material Split, Cut or Torn 6 6
Connection Problem 6 6
Mechanical Problem 6 6
Reflux within Device 5 5
Device Markings/Labelling Problem 5 5
Device Sensing Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Infusion or Flow Problem 4 4
Output Problem 4 4
Failure to Zero 4 4
Loss of or Failure to Bond 4 4
Backflow 3 3
Obstruction of Flow 3 3
Failure to Calibrate 3 3
Difficult to Insert 3 3
Material Integrity Problem 3 3
Inappropriate Waveform 3 3
Activation, Positioning or Separation Problem 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Gas/Air Leak 2 2
Improper Flow or Infusion 2 2
Fail-Safe Problem 2 2
Calibration Problem 2 2
Incomplete or Inadequate Connection 2 2
Material Puncture/Hole 2 2
Contamination 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
Display or Visual Feedback Problem 1 1
Corroded 1 1
Deflation Problem 1 1
Burst Container or Vessel 1 1
Complete Blockage 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
Failure to Select Signal 1 1
Device Slipped 1 1
Failure to Analyze Signal 1 1
Material Rupture 1 1
Failure to Sense 1 1
Priming Problem 1 1
Unexpected Color 1 1
Mechanical Jam 1 1
No Pressure 1 1
Unintended Movement 1 1
Component Misassembled 1 1
Explosion 1 1
Material Deformation 1 1
Blocked Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 400 400
No Consequences Or Impact To Patient 78 78
Blood Loss 23 23
No Known Impact Or Consequence To Patient 19 19
Insufficient Information 19 19
No Patient Involvement 17 17
Hemorrhage/Bleeding 16 16
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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