Events

Alerta De Seguridad para IntelliVue Information Center and Philips IntelliVue Information Center iX

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
    2012-12-07
  • Fecha de publicación del evento
    2012-12-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121207.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 information center and philips intellivue information center ix medical device supplier, philips healthcare, has issued a medical device safety alert regarding philips intellivue information center and philips intellivue information center ix. this issue affected all piic and piic ix products using hewlett packard rp5800 pcs. philips has identified that an internal audio cable connector may have diminished retention force due to damaged contacts. this diminished retention force could lead to intermittent or loss of audible alarms. failure to annunciate audio alarms may delay recognition of an alarm condition, if users do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system, e.G., a bedside monitor. this may result in delayed treatment of the patient. the manufacturer advises users to observe system for any of the described symptoms. if experiencing intermittent audio or there is no audio from the piic / piic ix, while it is not connected to another audible alarm annunciation system, users should not rely exclusively on the audible alarm system for patient monitoring. as this issue does not affect video functionality, visual alarming remains operational and close observation of the piic / piic ix display should be provided. philips will replace the audio cable on affected devices. according to the local supplier, 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 7 december 2012.

Device

IntelliVue Information Center and Philips IntelliVue Information Center iX
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips IntelliVue Information Center and Philips IntelliVue Information Center iX
  • Manufacturer
    Philips Healthcare

Manufacturer

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