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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
DIRECTED SYSTEMS LTD
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PULSION MEDICAL SYSTEMS SE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 81 81
2020 49 49
2021 29 29
2022 44 44
2023 8 8
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 137 137
Incorrect, Inadequate or Imprecise Result or Readings 91 91
Smoking 13 13
Device Displays Incorrect Message 10 10
Break 8 8
Operating System Becomes Nonfunctional 7 7
Output Problem 7 7
Temperature Problem 7 7
Therapeutic or Diagnostic Output Failure 6 6
High Test Results 6 6
Electrical Power Problem 5 5
Inaccurate Information 5 5
Sparking 4 4
Device Alarm System 3 3
Display or Visual Feedback Problem 3 3
Fire 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Intermittent Communication Failure 2 2
Material Fragmentation 2 2
Leak/Splash 2 2
No Display/Image 2 2
Low Test Results 2 2
High Readings 2 2
Ambient Temperature Problem 2 2
Battery Problem 2 2
Unable to Obtain Readings 2 2
Defective Device 2 2
Output below Specifications 2 2
Power Problem 1 1
Pressure Problem 1 1
Excessive Cooling 1 1
Inappropriate or Unexpected Reset 1 1
Material Twisted/Bent 1 1
Component Missing 1 1
Low Readings 1 1
Failure to Advance 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Overheating of Device 1 1
Loss of Power 1 1
Increase in Pressure 1 1
Thermal Decomposition of Device 1 1
Misassembly by Users 1 1
Data Problem 1 1
Noise, Audible 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 119 119
No Clinical Signs, Symptoms or Conditions 83 83
No Known Impact Or Consequence To Patient 78 78
No Patient Involvement 15 15
Superficial (First Degree) Burn 2 2
Alteration In Body Temperature 1 1
No Information 1 2
No Code Available 1 1
Insufficient Information 1 1
Reaction 1 1
Stroke/CVA 1 1
High Blood Pressure/ Hypertension 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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