Events

Alerta De Seguridad para Ondal AC2000 Spring-Loaded Arm

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

¿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
    2014-04-01
  • Fecha de publicación del evento
    2014-04-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140401.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: draeger ondal ac2000 spring-loaded arm the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ondal ac2000 spring-loaded arm, manufactured by draeger and up until the end of 2006. the affected part numbers are g19051, g19262, g93358 and g93359. the manufacturer has received case reports where a welded seam in the spring-loaded arm of the monitor holder broke. investigations revealed that the welded seam in the spring-loaded arm was unable in isolated cases to withstand the dynamic stress over years where monitors were frequently moved. the monitor is then at risk of falling. although no injury was reported, the risk of injury to persons positioned beneath the monitor cannot be excluded. the manufacturer advises users that monitors in the affected installations must not be positioned above people and that monitors must be moved with care (e.G. holding monitor in both hands) until the replacement has been carried out. in particular, monitors should not be positioned with considerable force – the stress on the lower joint of the spring-loaded arm should be minimized. the manufacturer would arrange replacement of the affected spring-loaded arm. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con394667 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 01 april 2014.

Device

Ondal AC2000 Spring-Loaded Arm
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Draeger Ondal AC2000 Spring-Loaded Arm
  • Manufacturer
    Draeger

Manufacturer

Draeger