Events

Alerta De Seguridad para Compact Suction Unit

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

¿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
    2015-04-27
  • Fecha de publicación del evento
    2015-04-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150427b.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: laerdal compact suction unit medical device manufacturer, laerdal, has issued a medical device safety alert concerning its laerdal compact suction unit [model number: 88005103 and 88006103; serial numbers: 150303a0479 to 150303a0493]. a limited number of laerdal compact suction unit 4 units placed on the market have been manufactured with a material that does not meet its specification. all affected units have passed the functional test performed before release and are capable of achieving maximum vacuum. however, lifetime and performance at operating temperature limits (high/ low temperatures) is unknown. therefore, the units with serial numbers listed above must be returned to the manufacturer. units with affected serial numbers must be removed from use. 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 27 april 2015.

Device

Compact Suction Unit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Laerdal Compact Suction Unit
  • Manufacturer
    Laerdal

Manufacturer

Laerdal