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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
TRANSONIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect, Inadequate or Imprecise Result or Readings 80
Incorrect Measurement 56
Smoking 11
Fire 5
Thermal Decomposition of Device 3
Ambient Temperature Problem 2
Sparking 2
Temperature Problem 2
Use of Device Problem 2
Device Issue 1
Capturing Problem 1
Inflation Problem 1
High Test Results 1
Data Problem 1
Device Operates Differently Than Expected 1
Improper Device Output 1
Melted 1
Positioning Failure 1
Display or Visual Feedback Problem 1
Improper or Incorrect Procedure or Method 1
Electrical /Electronic Property Problem 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 176

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC II Jul-25-2019
2 ICU Medical, Inc. II May-07-2020

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