“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Indicated as respiratory support by mechanical ventilation (conventional and / or high frequency among others) for premature patients, newborns and children who so require. Use: neonatal intensive care unit, pediatric intensive care unit, ambulatory care, delivery rooms, etc.).
Mechanical ventilation of premature babies, babies and small children under 20kg. In particular, they are used in the case of respiratory failure caused by ladifusion or respiratory mechanical disorder.
Performs controlled ventilation, assisted and combined in an invasive and non-invasive way in adult, pediatric and neonatal patients who need respiratory volumes of 2ml to 4000ml of tidal volume.