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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
Regulation Description Extravascular blood pressure transducer.
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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 81 81
Leak/Splash 59 59
Detachment Of Device Component 46 46
Disconnection 43 43
Fluid Leak 35 35
Break 34 34
Incorrect, Inadequate or Imprecise Resultor Readings 23 23
Detachment of Device or Device Component 13 13
Separation Problem 11 11
Inaccurate Information 5 5
Device Markings/Labelling Problem 5 5
Infusion or Flow Problem 5 5
Crack 5 5
Device Contamination with Chemical or Other Material 4 4
Device Operates Differently Than Expected 4 4
Reflux within Device 4 4
Connection Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Air Leak 3 3
Backflow 3 3
Mechanical Problem 3 3
High Readings 3 3
Loss of or Failure to Bond 3 3
Failure to Prime 3 3
Separation Failure 2 2
Activation, Positioning or SeparationProblem 2 2
Device Displays Incorrect Message 2 2
Material Split, Cut or Torn 2 2
Air/Gas in Device 2 2
Priming Problem 1 1
Gas Leak 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Pressure Problem 1 1
Reset Problem 1 1
Appropriate Term/Code Not Available 1 1
Fail-Safe Problem 1 1
Defective Device 1 1
Failure to Analyze Signal 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 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
Failure to Calibrate 1 1
Unintended Collision 1 1
No Device Output 1 1
Overheating of Device 1 1
Particulates 1 1
Difficult to Flush 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Partial Blockage 1 1
Burst Container or Vessel 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 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 91 91
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
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
Insufficient Information 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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