Events

Alerta De Seguridad para R40PED Powerchair

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Pride Mobility Products 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
    2013-08-28
  • Fecha de publicación del evento
    2013-08-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130828.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: pride mobility r40ped powerchair the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning r40ped powerchair manufactured by pride mobility products corporation. all the r40ped with mbl, ll-1000 power seat tilt actuator; manufactured from 26 april 2012 to 20 may 2013 are affected. the manufacturer has found that there is a potential for the stop bushing on the seating tilt actuator to fail. this may lead to a separation of the actuator’s internal components and the seat tilting backwards to a degree much greater than intended. furthermore, the end user may not have any means of detection for this failure mode prior to such an event. the manufacturer has received 2 consumer complaints on this issue. there is a potential that such a malfunction in the product can occur and could lead to serious personal injury and/or death. in order to alleviate any potential for this type of malfunction, the manufacturer will replace the affected actuator with a new assembly that has a more robust and proven stop bushing. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con306142 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 august 2013.

Device

R40PED Powerchair

Manufacturer

Pride Mobility Products Corporation