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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device injector, contrast medium, automatic
Product CodeIZQ
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ULRICH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 3 3
2018 7 7
2019 9 9
2020 13 13
2021 14 14
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Break 4 4
Detachment of Device or Device Component 3 3
Air/Gas in Device 3 3
Insufficient Information 2 2
Gas Leak 2 2
Improper Flow or Infusion 2 2
Connection Problem 2 2
No Display/Image 2 2
Device Displays Incorrect Message 2 2
Leak/Splash 2 2
Mechanical Problem 2 2
Self-Activation or Keying 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Defective Component 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Defective Device 1 1
Energy Output Problem 1 1
Increase in Pressure 1 1
Device Difficult to Program or Calibrate 1 1
Pumping Stopped 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Material Rupture 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Communication or Transmission Problem 1 1
Display or Visual Feedback Problem 1 1
Filling Problem 1 1
Fluid Leak 1 1
Excess Flow or Over-Infusion 1 1
Activation, Positioning or SeparationProblem 1 1
Complete Blockage 1 1
Computer Software Problem 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1
Unintended Electrical Shock 1 1
Backflow 1 1
Output Problem 1 1
Physical Property Issue 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 6 6
Pain 4 4
No Consequences Or Impact To Patient 4 4
Air Embolism 3 3
Infiltration into Tissue 3 3
Overdose 2 2
Extravasation 2 2
Pulmonary Embolism 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Death 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Electric Shock 1 1
No Patient Involvement 1 1
Respiratory Distress 1 1
No Code Available 1 1

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