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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

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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 96 96
Disconnection 49 49
Detachment Of Device Component 39 39
Fluid/Blood Leak 35 35
Break 34 34
Incorrect, Inadequate or Imprecise Result or Readings 26 26
Leak/Splash 17 17
Detachment of Device or Device Component 13 13
Separation Problem 12 12
Pressure Problem 10 10
Separation Failure 7 7
Unable to Obtain Readings 6 6
Inaccurate Information 6 6
Air/Gas in Device 5 5
Device Markings/Labelling Problem 5 5
Device Sensing Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Infusion or Flow Problem 4 4
Connection Problem 4 4
Reflux within Device 4 4
Crack 4 4
Incorrect Measurement 4 4
Mechanical Problem 4 4
Difficult to Flush 3 3
Loss of or Failure to Bond 3 3
Failure to Prime 3 3
Failure to Calibrate 3 3
High Readings 3 3
Inappropriate Waveform 3 3
Loose or Intermittent Connection 2 2
Difficult to Insert 2 2
Air Leak 2 2
Backflow 2 2
Activation, Positioning or Separation Problem 2 2
Device Displays Incorrect Message 2 2
Obstruction of Flow 2 2
Calibration Problem 2 2
Improper Flow or Infusion 2 2
Material Split, Cut or Torn 2 2
Priming Problem 1 1
Unexpected Color 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Blocked Connection 1 1
Device Operates Differently Than Expected 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Gas/Air Leak 1 1
Fail-Safe Problem 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Deflation Problem 1 1
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Material Fragmentation 1 1
Melted 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Particulates 1 1
Device Difficult to Setup or Prepare 1 1
Device Difficult to Program or Calibrate 1 1
Failure to Analyze Signal 1 1
Defective Device 1 1
Failure to Select Signal 1 1
Device Slipped 1 1
Device Inoperable 1 1
Device Contamination with Body Fluid 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 184 184
No Consequences Or Impact To Patient 130 130
No Known Impact Or Consequence To Patient 37 37
No Patient Involvement 25 25
Blood Loss 24 24
Hemorrhage/Bleeding 6 6
Death 4 4
No Information 3 3
Low Blood Pressure/ Hypotension 2 2
Exposure to Body Fluids 2 2
Insufficient Information 2 2
Air Embolism 1 1
Cardiac Arrest 1 1
Pneumothorax 1 1
Full thickness (Third Degree) Burn 1 1
Extubate 1 1
Atrial Flutter 1 1
Burn(s) 1 1
Chronic Obstructive Pulmonary Disease (COPD) 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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