Events

Alerta De Seguridad para PARI SOLE N Inhalation Device

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

¿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
    2012-09-11
  • Fecha de publicación del evento
    2012-09-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120911c.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: power adapter used in pari sole n inhalation device the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the power adapter manufactured by friwo used in pari sole n inhalation device. pari gmbh has received a small number of complaints regarding the mains adapter manufactured by friwo that is used with the pari sole n inhalation device. the complaints received concerned the mains adapter overheating and causing a certain part of the power adapter housing to melt. it may pose the risk of electric shock or fire. none of the reported incidents led to any personal injury or damage due to fire. the manufacturer advised users to inspect the power adapter before each use to ensure that it is not damaged. the device must not be switched on if damaged or damage is suspected. users should contact the manufacturer for replacement of the power adapter. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con184398 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 september 2012.

Device

PARI SOLE N Inhalation Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Power Adapter used in PARI SOLE N Inhalation Device
  • Manufacturer
    FRIWO

Manufacturer

FRIWO