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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
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 12 12
2024 22 23
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 139 139
Incorrect, Inadequate or Imprecise Result or Readings 99 99
Smoking 13 13
Device Displays Incorrect Message 10 10
Break 9 9
Leak/Splash 8 8
Output Problem 8 8
Operating System Becomes Nonfunctional 7 7
Temperature Problem 7 7
Fluid/Blood Leak 6 6
High Test Results 6 6
Therapeutic or Diagnostic Output Failure 6 6
Sparking 5 5
Inaccurate Information 5 5
Electrical Power Problem 5 5
Unable to Obtain Readings 4 4
Display or Visual Feedback Problem 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Detachment of Device or Device Component 3 3
Battery Problem 3 3
High Readings 3 4
Device Alarm System 3 3
Fire 3 3
Material Fragmentation 2 2
Defective Device 2 2
Insufficient Flow or Under Infusion 2 2
Low Readings 2 2
Ambient Temperature Problem 2 2
No Display/Image 2 2
Intermittent Communication Failure 2 2
Low Test Results 2 2
Output below Specifications 2 2
Component Missing 1 1
Material Twisted/Bent 1 1
Thermal Decomposition of Device 1 1
Failure to Transmit Record 1 1
Misassembly by Users 1 1
Data Problem 1 1
Energy Output Problem 1 1
Device Emits Odor 1 1
Material Separation 1 1
Increase in Pressure 1 1
Failure to Advance 1 1
Power Problem 1 1
Excessive Heating 1 1
Excessive Cooling 1 1
Communication or Transmission Problem 1 2
Overheating of Device 1 1
Inappropriate or Unexpected Reset 1 1
Loss of Power 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 110 111
No Known Impact Or Consequence To Patient 78 78
No Patient Involvement 15 15
Superficial (First Degree) Burn 2 2
Insufficient Information 2 2
High Blood Pressure/ Hypertension 1 1
Stroke/CVA 1 1
No Code Available 1 1
No Information 1 2
Alteration In Body Temperature 1 1
Reaction 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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