Events

Alerta De Seguridad para Fabius MRI anesthesia system

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

¿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
    2015-06-19
  • Fecha de publicación del evento
    2015-06-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150619c.html
  • 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: fabius mri anesthesia system medical device manufacturer, draeger medical, has issued a medical device safety alert concerning its fabius mri anaesthesia systems [part numbers: 9039036 and 9054649]. the manufacturer has become aware of cases where the fabius mri or parts of the system were attached by the magnetic field of the mri. according to the manufacturer, if the fabius mri was positioned too close to the mri, the magnetic force of the mri could loosen parts of the fabius mri and cause personal injury. there were reported cases that the incidents had happened when the device had been moved through the 40 mtesla area, even it was not in use. the manufacturer has amended the instructions for use, and decided to further improve the affected device by supplying the ventilator door with another lock in addition to the existing locking mechanism. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2015.

Device

Fabius MRI anesthesia system
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Fabius MRI anesthesia system
  • Manufacturer
    Draeger Medical

Manufacturer

Draeger Medical