Lifepak 500 AED

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
  • Source
    BAM

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Cases were distributed nationwide and internationally.
  • Descripción del producto
    Hard shell carry case for the LIFEPAK 500 AED.
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
  • Modelo / Serial
    Model Catalog: (Lot serial: 3005384-000 THROUGH -002)
  • Descripción del producto
    LIFEPAK 500 HARD-SHELL CASE
  • Manufacturer