Alerta De Seguridad para hs1 and heartstart frx automatic external defibrillators

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips Healthcare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: philips heartstart hs1 and heartstart frx automatic external defibrillators medical device manufacturer, philips healthcare, has issued an advisory regarding heartstart hs-1 and heartstart frx automatic external defibrillators. the manufacturer has determined that it is important to clarify information in the owner’s manual and keep the users of heartstart frx and hs1 informed about the maintenance of the frx or hs1 heartstart automated external defibrillators (aeds). the manufacturer advised users that in case of single chirps, if the frx or hs1 aed emits a pattern of single chirps(♪...♪...♪...), press the blue i-button on the front of the device for information. the aed will tell the user exactly what actions to take to ensure that the device is ready for use. in case of triple chirps, if at any time during the life of the device, the frx or hs1 aed emitted or begins to emit a pattern of triple chirps (♪♪♪...♪♪♪...♪♪♪...), it is important that the user remove the device from use, and contact the local philips representative. if an frx or hs1 aed emits a pattern of triple chirps, it is a signal that the device requires investigation by philips to ensure that it is ready for use. of course, if needed for use in an emergency, make every attempt to clear the error and use the device normally, as described in the owner’s manual. however, even if the user has been able to clear the error, it is important that the user contact the local philips representative to obtain the tools and information the user need to ensure that the device is functioning properly. users should update their protocols accordingly. in addition, the manufacturer has created a website with additional information about this action. to hear the difference between single chirps and triple chirps emitted by these aeds, visit the manufacturer’s website at www.Philips.Com/heartstartmaintenanceadvisory. according to the local supplier, philips electronics hong kong ltd., the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 november 2012.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart HS1 and HeartStart FRx Automatic External Defibrillators
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source