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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
Regulation Description Single-function, preprogrammed diagnostic computer.
Product CodeDXG
Regulation Number 870.1435
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIDCO LTD
  SUBSTANTIALLY EQUIVALENT 2
PULSION MEDICAL SYSTEMS SE
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 67 67
2017 62 62
2018 83 83
2019 81 81
2020 49 49
2021 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 183 183
Incorrect, Inadequate or Imprecise Resultor Readings 164 164
Smoking 29 29
Fire 13 13
Display or Visual Feedback Problem 11 11
Sparking 11 11
Output Problem 10 10
Device Displays Incorrect Message 10 10
High Test Results 8 8
Temperature Problem 8 8
Operating System Becomes Nonfunctional 8 8
Device Operates Differently Than Expected 7 7
Break 7 7
No Display/Image 6 6
Therapeutic or Diagnostic Output Failure 6 6
Device Alarm System 6 6
Electrical Power Problem 6 6
Unable to Obtain Readings 4 4
Failure to Power Up 4 4
Melted 3 3
Device Emits Odor 3 3
Failure to Zero 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Thermal Decomposition of Device 3 3
Leak/Splash 2 2
Low Test Results 2 2
High Readings 2 2
Low Readings 2 2
Ambient Temperature Problem 2 2
Battery Problem 2 2
Data Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Improper Device Output 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output below Specifications 2 2
Overheating of Device 2 2
Loss of Power 2 2
Use of Device Problem 2 2
Defective Device 2 2
Application Network Problem 1 1
Misassembly by Users 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Inaccurate Information 1 1
Excessive Cooling 1 1
Material Twisted/Bent 1 1
Component Missing 1 1
Device Issue 1 1
Failure to Calibrate 1 1
Inflation Problem 1 1
Crack 1 1
Positioning Failure 1 1
Low Audible Alarm 1 1
No Audible Alarm 1 1
Power Problem 1 1
Pressure Problem 1 1
Inappropriate or Unexpected Reset 1 1
Connection Problem 1 1
Failure to Advance 1 1
Loose or Intermittent Connection 1 1
Moisture Damage 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
Erratic or Intermittent Display 1 1
Electrical /Electronic Property Problem 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 228 228
No Known Impact Or Consequence To Patient 179 179
No Patient Involvement 53 53
No Clinical Signs, Symptoms or Conditions 9 9
Superficial (First Degree) Burn 2 2
No Code Available 2 2
Death 2 2
Necrosis 1 1
Blurred Vision 1 1
Injury 1 1
Reaction 1 1
Cardiopulmonary Arrest 1 1
Swelling 1 1
Alteration In Body Temperature 1 1
No Information 1 2
Stroke/CVA 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC II Jul-25-2019
2 ICU Medical, Inc. II Jan-14-2021
3 ICU Medical, Inc. II May-07-2020
4 Lidco Ltd II Dec-30-2020
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