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TPLC
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show TPLC since
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Device
transducer, blood-pressure, extravascular
Product Code
DRS
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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