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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
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 92 92
2018 82 82
2019 84 84
2020 41 41
2021 97 97
2022 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 96 96
Leak/Splash 59 59
Disconnection 47 47
Detachment Of Device Component 46 46
Fluid Leak 40 40
Break 37 37
Incorrect, Inadequate or Imprecise Resultor Readings 30 30
Detachment of Device or Device Component 13 13
Separation Problem 12 12
Pressure Problem 8 8
Inaccurate Information 6 6
Separation Failure 6 6
Unable to Obtain Readings 6 6
Crack 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 5 5
Air/Gas in Device 4 4
Device Operates Differently Than Expected 4 4
Connection Problem 4 4
Backflow 4 4
Reflux within Device 4 4
Incorrect Measurement 4 4
Mechanical Problem 3 3
Air Leak 3 3
Loss of or Failure to Bond 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Failure to Prime 3 3
High Readings 3 3
Inappropriate Waveform 2 2
Failure to Calibrate 2 2
Device Displays Incorrect Message 2 2
Activation, Positioning or SeparationProblem 2 2
Material Split, Cut or Torn 2 2
Loose or Intermittent Connection 2 2
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Difficult to Flush 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Partial Blockage 1 1
Deflation Problem 1 1
Burst Container or Vessel 1 1
Unintended Collision 1 1
No Device Output 1 1
Overheating of Device 1 1
Particulates 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Analyze Signal 1 1
Failure to Select Signal 1 1
Device Slipped 1 1
Device Inoperable 1 1
Failure to Zero 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Priming Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Reset Problem 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Gas Leak 1 1
Fail-Safe Problem 1 1
Calibration Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 201 201
No Clinical Signs, Symptoms or Conditions 154 154
No Known Impact Or Consequence To Patient 50 50
Blood Loss 27 27
No Patient Involvement 26 26
Hemorrhage/Bleeding 5 5
Death 4 4
No Information 4 4
Exposure to Body Fluids 3 3
Low Blood Pressure/ Hypotension 2 2
Insufficient Information 2 2
Pneumothorax 1 1
Extravasation 1 1
Cardiac Arrest 1 1
Air Embolism 1 1
Atrial Flutter 1 1
Patient Problem/Medical Problem 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Extubate 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Nov-05-2019
2 ICU Medical, Inc. II Mar-28-2019
3 Smiths Medical ASD Inc. II Apr-21-2021
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