Events

Alerta De Seguridad O Notificaciones De Seguridad para Dynamis and Gerialit with Dewert electrical control systems

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Hill-Rom.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/031
  • Número del evento
    CON272240
  • Fecha
    2013-05-10
  • Fecha de publicación del evento
    2013-05-10
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272240?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of serious injury to patients, staff and visitors. unintentional movement, including sudden collapse to its lowest position, can occur when the bed is connected to the mains supply. a field safety notice (fsn) was published on 01 march 2012.  however, the manufacturer has since advised that these beds should be fixed to their lowest position and the control system deactivated to remove the risk of injury.
  • Acción
    Identify affected beds. Consider removing affected beds from use if alternatives are available. If an alternative is not available: consider whether continuing to use the beds at their fixed, lowest position is acceptable if acceptable, fix the beds to their lowest position and contact the manufacturer for instructions on how to deactivate the Dewert control system. Confirm with the manufacturer your actions when completed.

Device

Dynamis and Gerialit with Dewert electrical control systems
  • Modelo / Serial
  • Descripción del producto
    Hospital beds: Dynamis and Gerialit with Dewert electrical control systems. Specific models numbers manufactured from October 1995 to June 2001 inclusive. Dynamis and Gérialit beds were manufactured with electrical control systems supplied by either Dewert or SKF. This notification applies only to Dewert systems, which are easily recognizable by the design of the lockout unit, as shown in the manufacturer’s Field Safety Notice, MOD 466. Affected model numbers: LI146B1—LI146BI, LI146D1—LI146DI, LI147B1—LI147D1, LI150A0—LI150B0, LI163B1—LI163C1, PRS0128, PRS0199, PRS0201, PRS2001.
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom