Device Recall Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). || Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. || Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Medical Systems North America Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Société-mère du fabricant (2017)
  • Source
    USFDA