Events

Alerta De Seguridad para BCI Remote Alarm Cables

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

¿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
    2013-04-10
  • Fecha de publicación del evento
    2013-04-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130410.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: smiths medical bci remote alarm cables the united states food and drug administration (fda) has posted a medical device safety alert issued by medical device manufacturer, smiths medical asd, concerning its bci remote alarm cables (no=normally open, nc=normally closed), used with 9004 the capnocheck capnography (plus or sleep) system, reorder numbers: ww3398no & ww3398nc [lot no.: ww3398no0820, ww3398no0847, ww3398no0948, ww3398nc0822, ww3398nc0847, and ww3398nc0947]. these cables were distributed in colorado, illinois, indiana, massachusetts, south carolina, and wisconsin from october, 2008 through september, 2012. the bci remote alarm cables are designed for use with the 9004 capnocheck capnography (plus or sleep) system to transfer alarm signals from the capnocheck capnography system to a remote alarm system. the manufacturer has become aware that, in rare instances, the bci remote alarm cables (bci cables) are not transferring alarms when used with some remote nurse alarm systems. these products may cause serious adverse health consequences, including death. according to fda, the manufacturer has notified its customers by an “urgent medical device field safety notice-recall” letter to instruct customers to inspect their inventory and remove all affected devices from use. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm347193.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 april 2013.

Device

BCI Remote Alarm Cables

Manufacturer

Smiths Medical ASD