Events

Alerta De Seguridad para expression information portal - ip5

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
    2013-10-16
  • Fecha de publicación del evento
    2013-10-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016a.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 expression information portal - ip5 the therapeutic goods administration (tga), australia issued a medical device safety alert concerning expression information portal - ip5, manufactured by philips. the affected product number is 865471 and the affected serial numbers are us23200375, us23200376, us23200377. if the affected product is in use or powered on for an extended period of time (exceeding 24 hours), it may lost all audio function. "all audio" includes touch screen and qrs/spo2 modulation tones and audible alarms. all other functionality of the affected product is unaffected (waveforms, numeric values, visual alarm indications). the manufacturer will contact the affected customer to arrange for a software update to correct the problem. end users are requested to power cycle the affected product once every 24 hours and to be aware not to rely solely on audible alarms for alerting of potentially critical patient events. .According to the local supplier, the affected products were not distributed in hong kong. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01052-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

expression information portal - ip5
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Expression Information Portal - IP5
  • Manufacturer
    Philips

Manufacturer

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