Events

Alerta De Seguridad para IntelliVue patient monitors

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
    2012-02-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120214b.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
    Field safety notice: philips intellivue patient monitors the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning philips intellivue patient monitors. philips has recently received reports that, under certain circumstances, alarms announced at the patient monitor are not announced (either visual or audible) at the central station. only the below referenced models with sw revision h (up to and including h.15.36) are affected. mp20 (m8001a), mp30 (m8002a), mp40 (m8003a), mp50 (m8004a), mp60 (m8005a), mp70 (m8007a), mp80 (m8008a), mp90 (m8010a), intelligent display d80 (m8016a), mx600 (865242), mx700 (865241) and mx800 (865240) if a patient develops a condition leading to an alarm and is being monitored with a monitor which has entered the state where alarm information is not communicated to the central station, clinical personnel monitoring the central station may not be advised of an alarm condition. this could cause a delayed response to the alarm condition of the patient. philips will conduct software upgrade to the affected devices. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

IntelliVue patient monitors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips IntelliVue patient monitors
  • Manufacturer
    Philips

Manufacturer

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