“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.
The RESPIRONICS V60 ventilator is a support ventilator whose purpose is to increase the patient's breathing. It is indicated for patients who can breathe spontaneously but require mechanical ventilation: patients with chronic respiratory insufficiency or obstructive sleep apnea in a hospital or other institution under the supervision of a doctor. The RESPIRONICS V200 fan is a mechanical fan that works with electricity and is controlled by a microprocessor. It has been designed to be used by qualified medical personnel to provide continuous or intermittent ventilatory support for adult, pediatric and neonatal patients according to medical prescription.