Alerta De Seguridad para Dynamis and Gerialit Beds with DEWERT electrical system

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

¿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
    2013-01-29
  • Fecha de publicación del evento
    2013-01-29
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: hill-rom dynamis and gerialit beds with dewert electrical system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning dynamis and gerialit beds manufactured between october 1995 and june 2001 with dewert electrical system, manufactured by hill-rom. the affected model numbers are li146b1—li146bi, li146d1—li146di, li147b1—li147d1, li150a0—li150b0, li163b1—li163c1, prs0128, prs0199, prs0201, prs2001. the manufacturer wants to make aware of a potential safety issue regarding dynamis and gerialit beds manufactured and shipped from october 1995 to june 2001 that have dewert control boxes. it is possible for there to be unintentional movement of the bed when it is plugged in, including sudden collapse to the lowest position. in an effort to mitigate the potential for injury, the manufacturer requested customers that the labels should be applied to both sides of the bed as a reminder where a hand should not be placed, and to not climb under the bed. the manufacturer also advised customers to make sure that staff, patients, caregivers, and visitors do not work or crawl under any bed or other areas where unintended quick return to lowest position or collapse of the bed could cause entrapment that serious injury of death could occur. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226926 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 january 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hill-Rom Dynamis and Gerialit Beds with DEWERT electrical system
  • Manufacturer

Manufacturer