Device Recall LIFEPAK 500 AED

  • 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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA