Events

Alerta De Seguridad para 25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Bayer 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
    2013-04-26
  • Fecha de publicación del evento
    2013-04-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426a.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: bayer healthcare 25-foot dc power cables shipped with medrad veris mr vital signs monitors medical device manufacturer, bayer healthcare, has issued a field safety notice concerning 25-foot dc power cables shipped with medrad veris mr vital signs monitors between february 2009 and february 2013 (catalogue number 3010556). according to the manufacturer, the affected power cables are being recalled due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. when the dc power supply is connected to both ac power (wall outlet) and the dc power cable, excessive heating of the dc power cable may occur. the manufacturer advises users to have visual inspection of the dc power cable against recall criteria provided by the manufacturer. the affected dc power cables confirmed by visual inspection will be replaced with new dc power cables. in the interim, users can still use the dc power cables by following instructions for safe use of dc power cable provided by manufacturer. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bayer HealthCare 25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors
  • Manufacturer
    Bayer HealthCare

Manufacturer

Bayer HealthCare
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DH