Device Recall LIFEPAK 500 AED

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    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.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Société-mère du fabricant (2017)
  • Source