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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
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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