inforMED
MalfunctionDXT

ANGIOMAT ILLUMENA INJECTOR SYSTEM

Received Jan 11, 2024 · Event occurred May 23, 2021

Report MW5150167 · MDR key 18501801

Device

Generic name

Injector And Syringe, Angiographic

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

USE PROCESS DESCRIPTION: (IT COULDN'T BE POWERED ON, AND THE INDICATOR LIGHT DIDN'T LIGHT UP.) EVENT CAUSE ANALYSIS DESCRIPTION: (BATTERY COULDN'T BE CHARGED.) THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).