Events

Alerta De Seguridad para Power Wheelchairs

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

¿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
    2013-10-07
  • Fecha de publicación del evento
    2013-10-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131007b.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: invacare power wheelchairs the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning power wheelchairs manufactured by invacare corporation. the following products are affected: invacare power wheelchairs with spj+ joysticks and mk6i driver controls (excluding all asl, sip-n-puff, and switch control systems) invacare power wheelchairs with spj+ joystick models manufactured between 9 september 2009 to 21 march 2013 invacare power wheelchairs with mk6i driver controls (excluding all asl, sip-n-puff and switch control systems) manufactured between 1 october 2006 to 21 march 2013 invacare has identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. in a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands. invacare is providing distributors with two options to correct the affected joystick: invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to invacare. invacare will engage a third party to complete the correction. distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. invacare will correspond with end users directly if this option is selected. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00977-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 october 2013.

Device

Power Wheelchairs
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Invacare Power Wheelchairs
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation