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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computer, diagnostic, pre-programmed, single-function
Product CodeDXG
Regulation Number 870.1435
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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
Temperature Problem 8 8
High Test Results 8 8
Operating System Becomes Nonfunctional 8 8
Device Operates Differently Than Expected 7 7
Electrical Power Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
No Display/Image 6 6
Overheating of Device 6 6
Device Alarm System 6 6
Thermal Decomposition of Device 6 6
Inaccurate Information 6 6
Unable to Obtain Readings 5 5
Failure to Power Up 4 4
Device Emits Odor 4 4
Leak/Splash 4 4
Improper Device Output 4 4
Melted 3 3
High Readings 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Failure to Zero 3 3
Loss of Power 3 3
Material Fragmentation 2 2
Low Test Results 2 2
Defective Device 2 2
Output below Specifications 2 2
Electrical /Electronic Property Problem 2 2
Intermittent Communication Failure 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Use of Device Problem 2 2
Data Problem 2 2
Material Integrity Problem 2 2
Ambient Temperature Problem 2 2
Low Readings 2 2
Improper or Incorrect Procedure or Method 2 2
Battery Problem 2 2
Energy Output Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Electro-Static Discharge 1 1
Failure to Advance 1 1
Power Problem 1 1
Material Discolored 1 1
Inflation Problem 1 1
Excessive Cooling 1 1
Material Twisted/Bent 1 1
Component Missing 1 1
No Audible Alarm 1 1
Failure to Calibrate 1 1
Increase in Pressure 1 1
Circuit Failure 1 1
Inappropriate or Unexpected Reset 1 1
Device Difficult to Program or Calibrate 1 1
Connection Problem 1 1
Noise, Audible 1 1
Crack 1 1
Low Audible Alarm 1 1
Imprecision 1 1
Device Damaged Prior to Use 1 1
Moisture Damage 1 1
Loose or Intermittent Connection 1 1
Erratic or Intermittent Display 1 1
Decrease in Pressure 1 1
Image Display Error/Artifact 1 1
Unintended Movement 1 1
Pressure Problem 1 1
Misassembly by Users 1 1
Positioning Failure 1 1
Application Network Problem 1 1
Unexpected Shutdown 1 1
Device Issue 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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