“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.
It includes a hand-operated thermometer with a battery attached to a base station. It measures the temperature by feeling the infrared emissions in the tympanic membrane at the ear canal. Oral, rectal, central and axillary temperatures are measured based on the tympanic reading. Indicated for use in patients in intensive care and for measurements of temperature in the membranatympanic.