Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
PULSION MEDICAL SYSTEMS SE
  SUBSTANTIALLY EQUIVALENT 2
RETIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 83 83
2019 81 81
2020 49 49
2021 29 29
2022 44 44
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 173 173
Incorrect, Inadequate or Imprecise Result or Readings 141 141
Smoking 17 17
Device Displays Incorrect Message 10 10
Output Problem 9 9
Fire 9 9
Break 9 9
Operating System Becomes Nonfunctional 8 8
Temperature Problem 8 8
Sparking 7 7
Display or Visual Feedback Problem 7 7
High Test Results 7 7
No Display/Image 6 6
Device Alarm System 6 6
Electrical Power Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Inaccurate Information 5 5
Unable to Obtain Readings 5 5
Failure to Zero 3 3
Device Emits Odor 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Intermittent Communication Failure 2 2
Defective Device 2 2
Output below Specifications 2 2
Ambient Temperature Problem 2 2
Battery Problem 2 2
Melted 2 2
Material Fragmentation 2 2
Leak/Splash 2 2
Low Test Results 2 2
Overheating of Device 2 2
Failure to Power Up 2 2
Decrease in Pressure 1 1
Increase in Pressure 1 1
Device Difficult to Program or Calibrate 1 1
Loss of Power 1 1
High Readings 1 1
Low Readings 1 1
Failure to Advance 1 1
Component Missing 1 1
Failure to Calibrate 1 1
Loose or Intermittent Connection 1 1
Image Display Error/Artifact 1 1
Moisture Damage 1 1
Energy Output Problem 1 1
Low Audible Alarm 1 1
No Audible Alarm 1 1
Electrical /Electronic Property Problem 1 1
Thermal Decomposition of Device 1 1
Crack 1 1
Erratic or Intermittent Display 1 1
Excessive Cooling 1 1
Inappropriate or Unexpected Reset 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Power Problem 1 1
Pressure Problem 1 1
Misassembly by Users 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 175 175
No Known Impact Or Consequence To Patient 120 120
No Clinical Signs, Symptoms or Conditions 76 76
No Patient Involvement 33 33
Superficial (First Degree) Burn 2 2
No Code Available 2 2
Insufficient Information 1 1
No Information 1 2
Alteration In Body Temperature 1 1
Reaction 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Death 1 1
High Blood Pressure/ Hypertension 1 1
Necrosis 1 1
Swelling 1 1
Blurred Vision 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
-
-