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 gas control unit, cardiopulmonary bypass
Product CodeDTX
Regulation Number 870.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 20 20
2015 16 16
2016 36 36
2017 41 41
2018 48 48
2019 53 53
2020 63 63
2021 77 77
2022 69 69
2023 68 68
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 220 220
Device Displays Incorrect Message 57 57
Appropriate Term/Code Not Available 35 35
Other (for use when an appropriate device code cannot be identified) 29 29
Infusion or Flow Problem 24 24
No Audible Alarm 20 20
Inaccurate Flow Rate 13 13
No Flow 13 13
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Insufficient Flow or Under Infusion 10 10
Improper Flow or Infusion 9 9
Device Operates Differently Than Expected 9 9
Device Alarm System 6 6
Output Problem 6 6
No Apparent Adverse Event 5 5
Unexpected Shutdown 4 4
Mechanical Problem 4 4
Use of Device Problem 4 4
Device Operational Issue 3 3
Device Sensing Problem 3 3
Gas/Air Leak 3 3
Incorrect Measurement 3 3
Erratic or Intermittent Display 3 3
Display or Visual Feedback Problem 2 2
Defective Alarm 2 2
Loss of Power 2 2
Increase in Pressure 2 2
Defective Component 2 2
Protective Measures Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Low Readings 1 1
Suction Problem 1 1
Calibration Problem 1 1
Electrical Shorting 1 1
Failure to Shut Off 1 1
Decrease in Pressure 1 1
Output above Specifications 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Alarm Not Visible 1 1
Air Leak 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 223 223
No Consequences Or Impact To Patient 122 122
No Patient Involvement 122 122
No Patient involvement 14 14
Low Oxygen Saturation 6 6
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 3 3
Hypoventilation 2 2
Hypoxia 1 1
Ischemia 1 1
Abnormal Blood Gases 1 1
Death 1 1
No Information 1 1

-
-