• 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
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 218 218
Appropriate Term/Code Not Available 24 24
No Audible Alarm 20 20
Infusion or Flow Problem 20 20
No Flow 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Inaccurate Flow Rate 7 7
No Apparent Adverse Event 5 5
Mechanical Problem 4 4
Insufficient Flow or Under Infusion 4 4
Unexpected Shutdown 4 4
Output Problem 3 3
Device Sensing Problem 3 3
Gas/Air Leak 2 2
Increase in Pressure 2 2
Device Alarm System 2 2
Defective Alarm 2 2
Protective Measures Problem 2 2
Loss of Power 1 1
Electrical Shorting 1 1
Decrease in Pressure 1 1
Improper Flow or Infusion 1 1
Inaccurate Delivery 1 1
Insufficient Information 1 1
Labelling, Instructions for Use or Training Problem 1 1
Suction Problem 1 1
Low Readings 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 223 223
No Patient Involvement 55 55
No Consequences Or Impact To Patient 44 44
Low Oxygen Saturation 5 5
No Known Impact Or Consequence To Patient 4 4
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

-
-