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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
  1.  K210669  Quantum Mini Ventilation Module
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210669  Quantum Mini Ventilation Module

MDR Year MDR Reports MDR Events
2016 36 36
2017 41 41
2018 48 48
2019 53 53
2020 63 63
2021 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 113 113
Device Displays Incorrect Message 56 56
Appropriate Term/Code Not Available 35 35
Infusion or Flow Problem 15 15
No Audible Alarm 14 14
Inaccurate Flow Rate 13 13
No Flow 10 10
Insufficient Flow or Under Infusion 8 8
Improper Flow or Infusion 7 7
Device Operates Differently Than Expected 7 7
Device Alarm System 5 5
Use of Device Problem 4 4
Device Operational Issue 3 3
Erratic or Intermittent Display 3 3
Incorrect Measurement 3 3
Mechanical Problem 3 3
Output Problem 3 3
Unexpected Shutdown 2 2
Loss of Power 2 2
Increase in Pressure 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Display or Visual Feedback Problem 2 2
Defective Alarm 2 2
Gas Leak 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Electrical Shorting 1 1
Failure to Shut Off 1 1
Calibration Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Alarm Not Visible 1 1
Air Leak 1 1
No Display/Image 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
Protective Measures Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 120 120
No Consequences Or Impact To Patient 102 102
No Clinical Signs, Symptoms or Conditions 80 80
No Known Impact Or Consequence To Patient 5 5
Low Oxygen Saturation 3 3
Hypoventilation 2 2
Hypoxia 1 1
Ischemia 1 1
Abnormal Blood Gases 1 1
Death 1 1
No Information 1 1
Insufficient Information 1 1

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