Events

Alerta De Seguridad para intellivue patient monitors and avalon fetal 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
    2014-10-15
  • Fecha de publicación del evento
    2014-10-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141015.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 intellivue patient monitors and avalon fetal monitors medical device manufacturer, philips, has issued a field safety notice (fsn) concerning: intellivue patient monitors with software revisions j.21.03 and j.21.19; and model (product) numbers of mp5 (m8105a), mp5sc (m8105as), mp5t (m8105at), and mp5 upgrades (m8105au, 866327) avalon fetal monitors with software revision j.30.58; and model (product) numbers of fm20 (m2702a), fm30 (m2703a) and fm50 (m2705a) in time-synchronized automatic/sequence mode the non-invasive blood pressure (nbp) automatic measurement series is stopped inadvertently, if the repetition interval is increased manually by the user (e.G. from 5 to 15 minutes) in between two consecutive measurements. a prompt message “any ongoing nbp measurement and automatic cycle stopped” is displayed and a single tone sounds when the measurement series is stopped. after the automated measurement series has been stopped, nbp numeric, repetition time, and time to next measurement are no longer displayed, i.E. the nbp numeric field is blank. if the nbp measurement is stopped, and a patient’s blood pressure is not being monitored, a delay in treatment could occur. customers with affected devices will be contacted to arrange a software upgrade to correct the issues. during the interim period until the software is upgraded, users should make sure, if the nbp repetition interval needs to be increased (e.G. from 5 to 15 minutes), to restart the automatic nbp measurement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 15 october 2014.

Device

intellivue patient monitors and avalon fetal monitors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips IntelliVue Patient Monitors and Avalon Fetal Monitors
  • Manufacturer
    Philips

Manufacturer

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