Alerta De Seguridad para Multi-function Defibrillation Electrodes

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

¿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
    2014-12-04
  • Fecha de publicación del evento
    2014-12-04
  • País del evento
  • Fuente del evento
    DH
  • 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: heart sync inc. multi-function defibrillation electrodes the united states food and drug administration (fda) posted a medical device safety alert concerning multi-function defibrillation electrodes manufactured by heart sync inc. all lots of the following catalogue numbers are affected: c100-philips - adult radiotransparent electrode c100ac-philips - adult radiotransparent electrode t100lo-philips - adult radiotransparent electrode t100-philips radiotranslucent electrode t100ac-philips radiotranslucent electrode the manufacturer notified customers of a voluntary urgent device correction for certain multi-function defibrillation electrodes due to a connector compatibility issue with philips automated external defibrillators (aed) models fr3 and frx defibrillator units. these electrodes will not connect with philips fr3 or frx aed units. the frx aed unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the fr3, however, does not require pre-connection and the user will not discover the incompatibility issue until the aed must be used. this may result in a delay in electrical therapy, which can lead to death or serious adverse consequences. the manufacturer is modifying the labeling to clarify that use of the affected electrodes are incompatible with certain aed units. philips fr3 and frx aed units should only be used with the electrodes specified in the equipment manuals. for details, please refer to the following link: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm425605.Htm http://www.Fda.Gov/safety/recalls/ucm425536.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 december 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Heart Sync Inc. Multi-function Defibrillation Electrodes
  • Manufacturer

Manufacturer