Events

Notificaciones De Seguridad De Campo acerca de Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Corona Medical.

¿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
    Field Safety Notice
  • Número del evento
    SN2011(29)
  • Fecha
    2011-11-28
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/corona-medical-bed-side-rails-1025-1031-sp-1027-range&id=3681f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    Corona medical bed side rails – 1025, 1031 & sp 1027 range are not compliant with the dimensional requirements of the applicable standards, which defines the minimum size and / or maximum areas with risk of trapping in an adult bed for medical use. these side rails require replacement.
  • Acción
    Corona Medical and MMS Medical have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.  The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected side rails.  3. Determine if you / your institution have medical devices affected by this issue.  4. If you / your institution have affected medical devices, follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that corrective action is completed on all affected medical devices.

Device

Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
  • Modelo / Serial
  • Descripción del producto
    Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
  • Manufacturer
    Corona Medical

Manufacturer

Corona Medical
  • Empresa matriz del fabricante (2017)
    Hacare
  • Source
    HPRA