Events

Alerta De Seguridad para heartstart frx, heartstart home, and heartstart onsite automated external defibrillators

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

¿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
    2018-03-14
  • Fecha de publicación del evento
    2018-03-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180314b.html
  • 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 frx, heartstart home, and heartstart onsite automated external defibrillators the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning heartstart frx, heartstart home, and heartstart onsite automated external defibrillators (aeds), manufactured by philips. the manufacturer has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. according to the manufacturer, virtually all of these resistor-related failures were detected through the device’s automatic self-testing, alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy. in the extremely rare circumstances, the automated tests fail to detect the aed’s inability to function normally, and fail to deliver a shock when one is needed, putting patients at risk of not receiving adequate therapy for their vf or vt, potentially resulting in serious injury, or even death. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-5-to-9-march-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 march 2018.

Device

heartstart frx, heartstart home, and heartstart onsite automated external defibrillators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart FRx, HeartStart Home, and HeartStart OnSite automated external defibrillators
  • Manufacturer
    Philips

Manufacturer

Philips
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH