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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
2019 9 9
2020 13 13
2021 14 14
2022 24 24
2023 16 16
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
No Apparent Adverse Event 6 6
Improper Flow or Infusion 6 6
Break 4 4
Insufficient Information 4 4
Detachment of Device or Device Component 3 3
Mechanical Problem 3 3
Air/Gas in Device 3 3
Leak/Splash 2 2
Excess Flow or Over-Infusion 2 2
No Display/Image 2 2
Use of Device Problem 2 2
Device Displays Incorrect Message 2 2
Gas/Air Leak 2 2
Infusion or Flow Problem 2 2
Communication or Transmission Problem 2 2
Operating System Becomes Nonfunctional 1 1
Unintended Electrical Shock 1 1
Difficult to Remove 1 1
Burst Container or Vessel 1 1
Improper or Incorrect Procedure or Method 1 1
Energy Output Problem 1 1
Explosion 1 1
Device Difficult to Program or Calibrate 1 1
Backflow 1 1
Increase in Pressure 1 1
Retraction Problem 1 1
No Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Patient Device Interaction Problem 1 1
Complete Blockage 1 1
Unexpected Shutdown 1 1
Protective Measures Problem 1 1
Fitting Problem 1 1
Unintended Movement 1 1
Pressure Problem 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1
Fluid/Blood Leak 1 1
Pumping Stopped 1 1
Inaccurate Delivery 1 1
Material Rupture 1 1
Difficult or Delayed Activation 1 1
Computer Software Problem 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
Extravasation 11 11
Air Embolism 10 10
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 6 6
Infiltration into Tissue 5 5
Pain 4 4
No Consequences Or Impact To Patient 4 4
Distress 1 1
Needle Stick/Puncture 1 1
Electric Shock 1 1
Pulmonary Embolism 1 1
Inflammation 1 1
Overdose 1 1
Eye Injury 1 1
Low Blood Pressure/ Hypotension 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Death 1 1

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