Events

Notificaciones De Seguridad De Campo acerca de Stryker Model 6100 M1 Ambulance Cot

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Stryker 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
    SN2010(012)
  • Fecha
    2010-09-30
  • 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=/stryker-model-6100-m1-ambulance-cot&id=6d8af825-9782-6eee-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
    Stryker has become aware that the head end slide tube, bushings and head end release rod of the model 6100 m1 ambulance cot can break during use, potentially resulting in the head end of the cot collapsing.
  • Acción
    As there are no sales records, the IMB are requesting that healthcare workers contact Stryker UK if they are aware that this device has been distributed in Ireland.  If affected devices are located at your facility and the unit does not operate properly, remove the unit from service and contact Stryker UK to arrange for a device retrofit / upgrade. The attached field safety notice issued by Stryker provides further information on this issue.

Device

Stryker Model 6100 M1 Ambulance Cot
  • Modelo / Serial
  • Descripción del producto
    Stryker Model 6100 M1 Ambulance Cot
  • Manufacturer
    Stryker Medical

Manufacturer

Stryker Medical
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HPRA