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TPLC
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Device
computer, diagnostic, pre-programmed, single-function
Product Code
DXG
Regulation Number
870.1435
Device Class
2
Premarket Reviews
Manufacturer
Decision
APPLIED PHYSIOLOGY PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
BOMED INC
SUBSTANTIALLY EQUIVALENT
1
CARDIOX CORP.
SUBSTANTIALLY EQUIVALENT
1
CHEETAH MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
DIRECTED SYSTEMS LTD
SUBSTANTIALLY EQUIVALENT
2
EDWARDS LIFESCIENCES
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC.
SUBSTANTIALLY EQUIVALENT
4
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
1
ICU MEDICAL
SUBSTANTIALLY EQUIVALENT
1
LIDCO LTD
SUBSTANTIALLY EQUIVALENT
2
LIDCO LTD.
SUBSTANTIALLY EQUIVALENT
2
PULSION MEDICAL SYSTEMS AG
SUBSTANTIALLY EQUIVALENT
1
PULSION MEDICAL SYSTEMS SE
SUBSTANTIALLY EQUIVALENT
3
PULSION MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
RETIA MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
1. K181372
Argos
TRANSONIC SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
4
MDR Year
MDR Reports
MDR Events
2014
44
44
2015
34
34
2016
67
67
2017
62
62
2018
83
83
2019
81
81
2020
49
49
2021
29
29
2022
44
44
2023
8
8
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Measurement
233
233
Incorrect, Inadequate or Imprecise Result or Readings
231
231
Smoking
33
33
Fire
14
14
Sparking
12
12
Device Displays Incorrect Message
11
11
Display or Visual Feedback Problem
11
11
Break
10
10
Output Problem
10
10
Operating System Becomes Nonfunctional
8
8
Temperature Problem
8
8
High Test Results
8
8
Device Operates Differently Than Expected
7
7
Electrical Power Problem
6
6
Therapeutic or Diagnostic Output Failure
6
6
Thermal Decomposition of Device
6
6
Device Alarm System
6
6
No Display/Image
6
6
Overheating of Device
6
6
Inaccurate Information
6
6
Unable to Obtain Readings
5
5
Device Emits Odor
4
4
Failure to Power Up
4
4
Leak/Splash
4
4
Improper Device Output
4
4
High Readings
3
3
Application Program Freezes, Becomes Nonfunctional
3
3
Melted
3
3
Loss of Power
3
3
Failure to Zero
3
3
Improper or Incorrect Procedure or Method
2
2
Material Fragmentation
2
2
Electrical /Electronic Property Problem
2
2
Intermittent Communication Failure
2
2
Appropriate Term/Code Not Available
2
2
Data Problem
2
2
Output below Specifications
2
2
Material Integrity Problem
2
2
Low Readings
2
2
Defective Device
2
2
Low Test Results
2
2
Use of Device Problem
2
2
Ambient Temperature Problem
2
2
Battery Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Connection Problem
1
1
Application Network Problem
1
1
Inappropriate or Unexpected Reset
1
1
Excessive Cooling
1
1
Failure to Advance
1
1
Material Twisted/Bent
1
1
Unintended Movement
1
1
Misassembly by Users
1
1
Noise, Audible
1
1
Unexpected Shutdown
1
1
Power Problem
1
1
Pressure Problem
1
1
Low Audible Alarm
1
1
No Audible Alarm
1
1
Circuit Failure
1
1
Crack
1
1
Positioning Failure
1
1
Material Discolored
1
1
Erratic or Intermittent Display
1
1
Image Display Error/Artifact
1
1
Imprecision
1
1
Inflation Problem
1
1
Moisture Damage
1
1
Loose or Intermittent Connection
1
1
Electro-Static Discharge
1
1
Device Damaged Prior to Use
1
1
Component Missing
1
1
Device Issue
1
1
Failure to Calibrate
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Energy Output Problem
1
1
Decrease in Pressure
1
1
Increase in Pressure
1
1
Device Difficult to Program or Calibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
267
267
No Known Impact Or Consequence To Patient
210
210
No Clinical Signs, Symptoms or Conditions
83
83
No Patient Involvement
56
56
Burn(s)
4
4
Death
2
2
No Code Available
2
2
Superficial (First Degree) Burn
2
2
Insufficient Information
1
1
No Information
1
2
Alteration In Body Temperature
1
1
Injury
1
1
Reaction
1
1
High Blood Pressure/ Hypertension
1
1
Necrosis
1
1
Swelling
1
1
Blurred Vision
1
1
Cardiac Arrest
1
1
Cardiopulmonary Arrest
1
1
Stroke/CVA
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, Llc
II
Feb-02-2012
2
Edwards Lifesciences, Llc
II
Oct-28-2010
3
GETINGE US SALES LLC
II
Jul-25-2019
4
Hospira Inc
II
Nov-09-2009
5
ICU Medical, Inc.
II
Jan-14-2021
6
ICU Medical, Inc.
II
May-07-2020
7
Lidco Ltd
II
Dec-30-2020
8
Transonic Systems Inc
II
Apr-18-2013
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