“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.
Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Bahamas, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Iran, Japan, Mexico, Netherlands, Peru, and Uruguay.
Description du dispositif
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. || This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. || The LIFEPAK 500 AED is intended for use in the pre-hospital and workplace and community environments. It has been tested to RTCA/DO-160D; "Environmental Conditions and Test Procedures for Airborne Equipment" (refer to Specifications on page 5-15 of the Operating Instructions 3005338-001). The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: -CPR training -AED training equivalent to that recommended by the American Heart Association -Training in the use of the LIFEPAK 500 AED.