Alerta De Seguridad para DigitalDiagnost Patient support for stitching

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

¿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
    2014-04-04
  • Fecha de publicación del evento
    2014-04-04
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: philips digitaldiagnost patient support for stitching medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its digitaldiagnost patient support for stitching. according to the manufacturer, the footboard of patient support for stitching can be fixed in upper position. when the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. if it falls down, it may hurt the operator’s or patient’s foot (e.G. when moving the stand or when the operator fails to fix it correctly upon moving the board up). the following factors are needed for the situation to occur: hook not correctly adjusted operator does not recognize that the hook does not click into place patient support is moved (wheeled around) hook does not hold foot in hazard area” 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. the affected users are advised to always check the right position of the hook and that the hook is locked. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 april 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips DigitalDiagnost Patient support for stitching
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH