Events

Notificaciones De Seguridad De Campo acerca de Cervical Halo Traction Apparatus

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Jerome 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
    SN2004(02)
  • Fecha
    2004-03-12
  • 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=/cervical-halo-traction-apparatus&id=8895f825-9782-6eee-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
    The potential for imaging problems ranging from artifact, sparking, vibration, patient discomfort and / or surface burns when the cervical halo device is worn during a mri scan.
  • Acción
    Ensure that all devices that are sold as single use devices are only use once Ensure that MRI compatible devices are configured and positioned in the MRI so as to ensure that they are not too close to the MRI core and that metal components are not  criss-crossing or concentrated in one area  Ensure that the use of all MRI compatible devices are reviewed when any changes are made to the MRI strength to ensure that they still remain compatible  Ensure that patients screening forms are completed for all patients. (see form attached checklist) Report any indications of problems to the IMB

Device

Cervical Halo Traction Apparatus
  • Modelo / Serial
  • Descripción del producto
    Cervical Halo Traction Apparatus
  • Manufacturer
    Jerome Medical

Manufacturer

Jerome Medical
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    HPRA